| 1 |
NCT02895802 |
Completed |
Assessing the Feasibility of the Use of Visual Aids in Patient Education in Adults With Down Syndrome (DS) |
|
- Behavioral: Verbal instructions with picture diagram
- Behavioral: Verbal instructions with video of ADSC
- Behavioral: verbal instructions w. video of w/o DS
- Behavioral: verbal instructions w. video w/DS
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Score on handwashing checklist
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02895802 |
6360 |
|
August 2016 |
December 2016 |
October 25, 2017 |
September 12, 2016 |
January 23, 2019 |
|
- Adult Down Syndrome Center / Russell Institute for Research and Innovation
Park Ridge, Illinois, United States
|
|
| 2 |
NCT03903666 |
Not yet recruiting |
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome |
|
- Other: Nocturnal gaz exchanges measurement
|
Interventional
|
Not Applicable |
- Institut Jerome Lejeune
- Hôpital Armand Trousseau
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings
- Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %
- Number of patients with low mean, minimum and maximum SpO2 (oyxygen saturation) and/or % of Total sleep time spent with a PtcCO2 higher than 50 mmHg, higher than 20%, as measured by nocturnal gas exchange recordings.
- (and 3 more...)
|
47 |
All |
4 Years to 16 Years (Child) |
NCT03903666 |
TriRespi |
|
April 30, 2019 |
June 30, 2020 |
June 30, 2020 |
April 4, 2019 |
April 8, 2019 |
|
- Hôpital Armand Trousseau
Paris, France
|
|
| 3 |
NCT01950624 |
Recruiting |
DS-Connect {TM}: The Down Syndrome Registry |
|
|
Observational
|
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- To identify individuals with DS who may be eligible for research studies or new clinical trials, based on specific information about their diagnosis and health history.
- To determine the prevalence and various phenotypic manifestations of DS.
- Aggregate data from individuals with DS globally. Enable researchers to use de-identified data to analyze the etiology, natural history, and/or treatment effectiveness in DS. Help medical professionals improve treatments for those with DS.
- Study why individuals with DS have different symptoms. Allow individuals with DS and their families to look at their information in DS-Connect and compare it to de-identified information from other participants in the Registry.
|
100000 |
All |
1 Year and older (Child, Adult, Older Adult) |
NCT01950624 |
999913201
13-CH-N201 |
|
September 6, 2013 |
May 26, 2024 |
May 26, 2024 |
September 25, 2013 |
June 13, 2019 |
|
- National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, United States
|
|
| 4 |
NCT03087500 |
Withdrawn |
Physiological Abnormalities Associated With Down Syndrome |
|
|
Observational
|
|
- University of Arkansas
- Down Syndrome Research Foundation
- Arkansas Children Research Institute
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Microbiome Analysis
- Mitochondrial Function Analysis
- Oxidative Stress Analysis
- (and 6 more...)
|
0 |
All |
3 Years to 50 Years (Child, Adult) |
NCT03087500 |
IRB: #206522 |
|
October 2017 |
September 2019 |
December 2019 |
March 22, 2017 |
October 27, 2017 |
|
|
|
| 5 |
NCT02882698 |
Completed |
Performance Analysis in Down Syndrome on Mobile Phone |
|
- Behavioral: Down Syndrome Group 1
- Behavioral: Down Syndrome Group 2
- Behavioral: Typical Development Group 1
- Behavioral: Typical Development Group 2
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Improvement of performance
|
100 |
All |
11 Years to 35 Years (Child, Adult) |
NCT02882698 |
341/1 |
|
September 2016 |
November 2016 |
December 2016 |
August 30, 2016 |
April 11, 2017 |
|
- Associacao de Pais e Amigos dos Excepcionais de Amparo (APAE)
Amparo, Sao Paulo, Brazil
|
|
| 6 |
NCT01303133 |
Completed |
Natural History of Amyloid Deposition in Adults With Down Syndrome |
|
|
Observational
|
|
- University of Pittsburgh
- National Institute on Aging (NIA)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
81 |
All |
30 Years and older (Adult, Older Adult) |
NCT01303133 |
PRO09080266
2R01AG031110-03A1 |
|
August 2009 |
March 31, 2018 |
March 31, 2018 |
February 24, 2011 |
January 9, 2019 |
|
- University of Pittsburgh and University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States - Waisman Center at the University of Wisconsin - Madison
Madison, Wisconsin, United States
|
|
| 7 |
NCT03935620 |
Recruiting |
Delivering Early Intervention to Children With Down Syndrome |
|
- Behavioral: Enhanced Milieu teaching
|
Interventional
|
Not Applicable |
- Oregon Health and Science University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Between Session Change:Number of EMT Strategies Used by Parents During Parent-Child Interaction
- Between Session Change: Rate of Symbolic Communication During Parent-Child Interaction
- Communication Matrix Scores
- Between Session Change: Number of Different Words Expressed During Parent-Child Interaction
|
10 |
All |
18 Months to 36 Months (Child) |
NCT03935620 |
STUDY00018508 |
|
May 15, 2019 |
March 1, 2020 |
September 1, 2021 |
May 2, 2019 |
May 14, 2019 |
|
- Oregon Health and Science University
Portland, Oregon, United States
|
|
| 8 |
NCT00748007 |
Completed |
Efficacy of Rivastigmine in Patients With Down Syndrome |
|
|
Interventional
|
Not Applicable |
- National Taiwan University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Scores of Vineland Adaptive Behavior Scales (VABS), Scores of WISC digit span, Scores of Leiter-R Forward memory , Scores of PPVT,
- Scores of NEPSY test for Visuospatial and Design Coping, Scores of Visuomotor Precision, Scores of WPPSI Sentences, Scores of Score for Character Recognitions by School Grade, and Scores of Test for Mathematic Ability for Children
|
14 |
All |
8 Years and older (Child, Adult, Older Adult) |
NCT00748007 |
200709028M |
|
January 2008 |
December 2009 |
December 2009 |
September 8, 2008 |
November 28, 2012 |
|
- Department of Medical Genetics, National Taiwan University Hospital
Taipei, Taiwan
|
|
| 9 |
NCT01598350 |
Completed
Has Results |
Gait in Children With Down Syndrome While Wearing Orthoses |
|
- Device: Supramalleolar Orthoses (Cascade)
|
Interventional
|
Not Applicable |
- University of Puget Sound
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
|
6 |
All |
2 Years to 10 Years (Child) |
NCT01598350 |
0910-003 |
|
January 2010 |
June 2011 |
June 2011 |
May 15, 2012 |
December 30, 2013 |
December 30, 2013 |
- University of Puget Sound
Tacoma, Washington, United States
|
|
| 10 |
NCT03590665 |
Recruiting |
Blood Flow in Individuals With Down Syndrome |
|
- Other: Hand grip exercise and lower body negative pressure
|
Interventional
|
Not Applicable |
- University of Illinois at Chicago
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Brachial blood flow
- Muscle oxygenation
- Cardiac outut
|
70 |
All |
18 Years to 45 Years (Adult) |
NCT03590665 |
1K99HD092606-01 |
|
March 1, 2018 |
June 1, 2019 |
June 1, 2019 |
July 18, 2018 |
July 18, 2018 |
|
- Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd
Chicago, Illinois, United States
|
|
| 11 |
NCT02094053 |
Completed |
A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living. |
|
- Drug: E2020-Donepezil hydrochloride
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Eisai Co., Ltd.
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Changes in total scores from baseline using Body Functionality Checklist (psychosomatic function questionnaire) in subjects with Down syndrome having regression symptoms and disabled activities of daily living (ADL), relative to placebo.
- Safety of E2020 and placebo in subjects with Down syndrome having regression and disabled ADL.
- Pharmacokinetics (PK) of E2020 and placebo in subjects with Down syndrome having regression and disabled ADL
|
36 |
All |
15 Years to 39 Years (Child, Adult) |
NCT02094053 |
E2020-J081-345 |
|
September 12, 2013 |
September 16, 2016 |
April 21, 2017 |
March 21, 2014 |
August 22, 2017 |
|
- Fukuoka-shi, Fukuoka, Japan
- Sapporo-shi, Hokkaido, Japan
- Yokohama-shi, Kanagawa, Japan
- (and 7 more...)
|
|
| 12 |
NCT01390558 |
Completed |
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite |
|
- Procedure: custom orthotics
|
Observational
|
|
- Oregon Health and Science University
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Gait will be measured with the GaitRite gait evaluation system.
- Elucidate patterns in the development of walking in persons with Down Syndrome using GaitRite®.
|
23 |
All |
2 Years to 80 Years (Child, Adult, Older Adult) |
NCT01390558 |
Gait Parameters Down Syndrome |
|
June 2011 |
August 27, 2018 |
August 27, 2018 |
July 11, 2011 |
February 15, 2019 |
|
- Child Development and Rehabilitation Center
Portland, Oregon, United States
|
|
| 13 |
NCT03267602 |
Completed |
Role of Sleep Apnea in the Neuropsychological Function in Down Syndrome People |
|
|
Interventional
|
Not Applicable |
- National Taiwan University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assessed the sleep apnea level with Apnoea-Hypopnoea Index (AHI) score.
- Assessed neuropsychological functions with Wechsler Preschool and Primary Scale of Intelligence (WPPSI-R) vocabulary subdomain score.
- Assessed the memory domain that subtest of Sentence (WPPSI-R) .
- (and 8 more...)
|
45 |
All |
Child, Adult, Older Adult |
NCT03267602 |
201208075RIC |
|
December 2012 |
December 2016 |
December 2016 |
August 30, 2017 |
September 5, 2017 |
|
|
|
| 14 |
NCT03058640 |
Completed |
Effects of Karate in Adolescents With Down Syndrome |
|
|
Interventional
|
Not Applicable |
- University of Michigan
- Down Syndrome Association of Toledo
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Balance
- 20m shuttle run
- standing long jump
- (and 7 more...)
|
16 |
All |
12 Years to 18 Years (Child, Adult) |
NCT03058640 |
00116460 |
|
July 15, 2017 |
March 31, 2019 |
March 31, 2019 |
February 23, 2017 |
May 20, 2019 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 15 |
NCT02127515 |
Unknown † |
Non Invasive Prenatal Testing of Down Syndrome |
|
- Procedure: Non Invasive Prenatal Testing
- Procedure: Invasive Prenatal Testing
|
Interventional
|
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number or miscarriages
- Number or invasive tests
- false positive and negative rates of NIPT
- (and 2 more...)
|
2450 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02127515 |
P130601
2013-A00998-37 |
SAFE 21 |
April 2014 |
April 2016 |
December 2016 |
April 30, 2014 |
November 13, 2015 |
|
- Hôpital Necker- Enfants Malades
Paris, France
|
|
| 16 |
NCT03192540 |
Active, not recruiting |
The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome |
|
|
Interventional
|
Not Applicable |
- Boston Children’s Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Home Exercise Compliance
- Muscular endurance
- Aerobic capacity
- (and 4 more...)
|
8 |
All |
12 Years to 17 Years (Child) |
NCT03192540 |
P00023661 |
DSFIT |
September 15, 2018 |
January 12, 2019 |
January 31, 2019 |
June 20, 2017 |
November 21, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
|
| 17 |
NCT00844259 |
Completed |
Functional Communicative Profile of Children With Down Syndrome |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Crossover
- Time Perspective: Cross-Sectional
|
|
15 |
All |
5 Years to 8 Years (Child) |
NCT00844259 |
180875 |
|
July 2006 |
October 2007 |
October 2007 |
February 16, 2009 |
February 16, 2009 |
|
- University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Sao Paulo, Brazil
|
|
| 18 |
NCT02719600 |
Completed |
Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome |
|
- Behavioral: Virtual reality
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Motor Learning test by using a timing coincident task in virtual reality
|
40 |
All |
11 Years to 28 Years (Child, Adult) |
NCT02719600 |
1033/03 |
|
March 2015 |
March 2016 |
March 2016 |
March 25, 2016 |
March 25, 2016 |
|
|
|
| 19 |
NCT01663675 |
Recruiting |
Trisomy 21 in Adulthood |
|
|
Observational
|
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT01663675 |
5249 |
|
November 2014 |
October 2019 |
October 2019 |
August 13, 2012 |
November 23, 2016 |
|
- Hôpitaux Universitaires de Strasbourg
Strasbourg, France
|
|
| 20 |
NCT01758718 |
Completed |
Eyelash Line Resection for Entropion Associated With Down's Syndrome |
|
- Procedure: Eyelash line resection
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Grading scale of superficial punctate keratopathy
- Score of wearing glasses
|
24 |
All |
3 Years to 90 Years (Child, Adult, Older Adult) |
NCT01758718 |
Kyorineye009
Entropion with Down's syndrome |
|
April 2007 |
March 2012 |
October 2012 |
January 1, 2013 |
January 1, 2013 |
|
- Kyorin Eye Center
Mitaka, Tokyo, Japan
|
|
| 21 |
NCT00952354 |
Unknown † |
Oral Language in Children With Down Syndrome |
|
|
Observational
|
|
- University of Sao Paulo
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
60 |
All |
3 Years to 10 Years (Child) |
NCT00952354 |
473492/2007-5
CNPq-473492/2007-5 |
|
August 2007 |
April 2009 |
August 2009 |
August 6, 2009 |
August 6, 2009 |
|
- University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Sao Paulo, Brazil
|
|
| 22 |
NCT02738450 |
Recruiting |
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome |
|
- Biological: ACI-24 low dose
- Biological: ACI-24 high dose
- Biological: Placebo
|
Interventional
|
Phase 1 |
- AC Immune SA
- National Institute on Aging (NIA)
- Alzheimer's Disease Cooperative Study (ADCS)
- LuMind Research Down Syndrome Foundation
|
Industry / NIH / Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of patients with treatment emergent adverse events and serious adverse events
- Antibody titer (serum anti-Aβ Ig)
- Change from baseline over 25 months on CANTAB battery
- (and 8 more...)
|
24 |
All |
25 Years to 45 Years (Adult) |
NCT02738450 |
ACI-24-1301
1R01AG047922-01 |
3 Star |
March 2016 |
March 2020 |
March 2021 |
April 14, 2016 |
May 23, 2018 |
|
- St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States - UCSD Adult Down Syndrome Program
La Jolla, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 23 |
NCT02432716 |
Active, not recruiting |
Investigation of the Safety of Intranasal Glulisine in Down Syndrome |
|
- Drug: Insulin glulisine
- Drug: Saline
|
Interventional
|
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety measured by adverse events
- Feasibility measured by CAMDEX-DS
- Cognitive change measured by Fuld Object-Memory Evaluation
- Cognitive change measured by Reivermead Behavioral Memory Test
|
12 |
All |
35 Years to 80 Years (Adult, Older Adult) |
NCT02432716 |
HealthPartnersRF |
|
April 2015 |
April 2019 |
April 2019 |
May 4, 2015 |
December 13, 2018 |
|
- HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
|
|
| 24 |
NCT00954382 |
Unknown † |
Trends in Intellectual Development in Down Syndrome |
|
|
Observational
|
|
- National Taiwan University Hospital
|
Other |
- Time Perspective: Retrospective
|
|
60 |
All |
3 Months to 40 Years (Child, Adult) |
NCT00954382 |
200904037R |
|
May 2009 |
December 2009 |
December 2010 |
August 7, 2009 |
March 18, 2010 |
|
|
|
| 25 |
NCT02288702 |
Recruiting |
Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome |
|
- Device: monitoring BIS in both groups
|
Observational
|
|
- Milton S. Hershey Medical Center
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- measure BIS values in the normal patients and those with Down syndrome under anesthesia
|
50 |
All |
2 Years to 17 Years (Child) |
NCT02288702 |
STUDY00000604 |
|
October 2014 |
February 2020 |
February 2020 |
November 11, 2014 |
February 4, 2019 |
|
- Hershey Medical Center
Hershey, Pennsylvania, United States
|
|
| 26 |
NCT00891917 |
Completed |
Liq-NOL Efficacy in Pediatric Patients With Down Syndrome |
|
|
Interventional
|
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation.
- To evaluate the effects of LiQ-NOL on child behavior.
|
30 |
All |
6 Years to 16 Years (Child) |
NCT00891917 |
04-12-4 |
|
January 2005 |
November 2012 |
December 2012 |
May 1, 2009 |
January 29, 2014 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 27 |
NCT02481765 |
Recruiting |
Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome |
|
- Device: High definition transcranial direct current stimulation
|
Interventional
|
Phase 1 |
- University of Wisconsin, Madison
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- Feasibility and tolerability of HD-tDCS in healthy adult subjects
- Feasibility and tolerability of HD-tDCS in adults with Down syndrome
- Collect pilot data on safety of HD-tDCS in healthy adults
- (and 3 more...)
|
10 |
All |
18 Years to 45 Years (Adult) |
NCT02481765 |
2014-0262 |
|
June 2015 |
November 2019 |
June 2020 |
June 25, 2015 |
January 10, 2019 |
|
- Department of Neurology, University of Wisconsin Madison
Madison, Wisconsin, United States
|
|
| 28 |
NCT02484703 |
Terminated |
A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of Age |
|
- Drug: Placebo
- Drug: RO5186582
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants With Adverse Events (AEs)
- Percentage of Participants With Epileptiform Abnormalities as Assessed Using Electroencephalogram (EEG) Analysis
- Percentage of Participants by Suicidality Classification as Assessed Using an Adapted Form of the Columbia Classification Algorithm for Suicide Assessment (C-CASA)
- (and 18 more...)
|
45 |
All |
6 Years to 11 Years (Child) |
NCT02484703 |
WP28760 |
|
October 28, 2015 |
August 3, 2016 |
August 3, 2016 |
June 30, 2015 |
July 6, 2017 |
|
- Southwest Autism Research & Resource Center
Phoenix, Arizona, United States - Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States - Rush University Medical Center
Chicago, Illinois, United States - (and 6 more...)
|
|
| 29 |
NCT00825175 |
Completed
Has Results |
Treadmill Training and Orthotic Use in Infants With Down Syndrome |
|
- Behavioral: Treadmill Training
- Device: Supramalleolar Orthoses
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pattern of Gross Motor Development
|
22 |
All |
6 Months to 36 Months (Child) |
NCT00825175 |
HUM00002466 |
|
March 2006 |
June 2008 |
June 2008 |
January 19, 2009 |
December 4, 2017 |
January 24, 2014 |
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 30 |
NCT01084135 |
Completed
Has Results |
Rivastigmine Study in Adolescents With Down Syndrome |
|
- Drug: Rivastigmine
- Other: Liquid Placebo
|
Interventional
|
Phase 1
Phase 2 |
- Duke University
- Taishoff Family Foundation
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)
- Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)
|
42 |
All |
10 Years to 17 Years (Child) |
NCT01084135 |
Pro00013682 |
DS-Riv |
November 2009 |
February 2014 |
February 2014 |
March 10, 2010 |
April 6, 2015 |
March 12, 2015 |
- Kennedy Krieger Institute
Baltimore, Maryland, United States - Duke University Medical Center
Durham, North Carolina, United States
|
|
| 31 |
NCT02431117 |
Completed |
Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30 |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values.
|
43 |
All |
6 Years to 30 Years (Child, Adult) |
NCT02431117 |
JP29688 |
|
June 2015 |
July 2016 |
July 2016 |
April 30, 2015 |
July 11, 2016 |
|
- Sapporo, Hokkaido, Japan
- Yokohama, Kanagawa, Japan
- Izumi, Osaka, Japan
- (and 4 more...)
|
|
| 32 |
NCT02380638 |
Completed |
Effects of Whole-body Vibration Training on Body Composition in Adolescents With and Without Down Syndrome |
|
- Device: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.
- Changes from baseline in bone structure evaluated with peripheral quantitative computed tomography at different time points, 6 months and 15 months.
|
58 |
All |
10 Years to 19 Years (Child, Adult) |
NCT02380638 |
DEP2009-09183 |
|
January 2010 |
June 2012 |
December 2012 |
March 5, 2015 |
March 5, 2015 |
|
- GENUD Research Group
Zaragoza, Spain
|
|
| 33 |
NCT00668980 |
Completed |
Symbolic Representation in Young Children With Down Syndrome |
|
|
Observational
|
|
- University of Sao Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Performance on monthly assessments administered after the initial evaluation
|
25 |
All |
Child, Adult, Older Adult |
NCT00668980 |
06/50842-4 |
|
July 2006 |
April 2009 |
April 2009 |
April 29, 2008 |
January 14, 2010 |
|
- APAE Sao José dos Campos
Sao Jose Dos Campos, Sao Paulo, Brazil - University Hospital
Sao Paulo, São Paulo, Brazil - University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
Sao Paulo, Brazil
|
|
| 34 |
NCT02451657 |
Completed |
Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Neurocognitive batteries/tests/scales: Suitability for individuals with Down syndrome assessed by number of tests completed/subjects completing, ceiling/floor effect, variance estimate of baseline/change from baseline
- Test/re-test reliability: Changes in test results over 6 months
- Influence of age on several neurocognitive tests and functioning scales in the Down syndrome population
- Correlations between test results on functioning, adaptive behavior and cognition and IQ level
|
40 |
All |
6 Years to 11 Years (Child) |
NCT02451657 |
BP29589 |
|
June 2, 2015 |
June 30, 2016 |
June 30, 2016 |
May 22, 2015 |
October 25, 2017 |
|
- University of Arizona
Tucson, Arizona, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - Duke Clin Rsch Institute
Durham, North Carolina, United States - (and 7 more...)
|
|
| 35 |
NCT01576705 |
Completed |
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children |
|
- Drug: thyroid hormone and folinic acid
|
Interventional
|
Phase 3 |
- Institut Jerome Lejeune
- Hôpital Cochin
- Central Hospital, Nancy, France
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- GMDS ( Griffiths Mental Development Scale)
- BL (Brunet Lezine revised scale)
|
175 |
All |
6 Months to 18 Months (Child) |
NCT01576705 |
IJL-AFHT-TH10 |
ACTHYF |
April 2012 |
December 14, 2017 |
December 14, 2017 |
April 12, 2012 |
March 26, 2019 |
|
- Institut Jerome Lejeune
Paris, France
|
|
| 36 |
NCT02024789 |
Completed |
A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) |
|
- Drug: Placebo
- Drug: RG1662
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Cognition as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) sub-tests
- Adaptive behavior as assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) standard scores
- Clinical global impression as assessed by Clinician Rated Global Improvement (CGI-I) scale
- (and 5 more...)
|
173 |
All |
12 Years to 30 Years (Child, Adult) |
NCT02024789 |
BP27832
2013-001263-23 |
|
May 5, 2014 |
May 4, 2016 |
May 4, 2016 |
December 31, 2013 |
October 25, 2017 |
|
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States - University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior
Sacramento, California, United States - Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States - (and 34 more...)
|
|
| 37 |
NCT03783338 |
Recruiting |
Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Cognition, Balance and Physical Performance in Children With Down Syndrome |
- Children With Down Syndrome
|
- Combination Product: Aerobic exercises and Vitamin D supplementation
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognition
- Balance
- Physical performance
|
45 |
All |
8 Years to 12 Years (Child) |
NCT03783338 |
P.T.REC/012/002143 |
|
December 2, 2018 |
March 2, 2019 |
March 2, 2019 |
December 21, 2018 |
December 21, 2018 |
|
- Faculty of Physical Therapy - Cairo University
Cairo, Giza, Egypt
|
|
| 38 |
NCT00570128 |
Completed |
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome |
|
- Drug: Donepezil hydrochloride
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Vineland-II Adaptive Behavior Scale (VABS-II); Parent/Caregiver Rating Form (PCRF)
- The Test of Verbal Expression and Reasoning (TOVER); Population PK (drug levels in the body), PD (drug effects) and safety will also be assessed.
|
150 |
All |
10 Years to 17 Years (Child) |
NCT00570128 |
E2020-A001-219 |
|
December 2007 |
September 2008 |
December 2008 |
December 10, 2007 |
August 6, 2009 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - Clinical Study Centers, L.L.C.
Little Rock, Arkansas, United States - Neufeld Medical Group, Inc.
Los Angeles, California, United States - (and 28 more...)
|
|
| 39 |
NCT00294593 |
Completed |
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome |
|
|
Interventional
|
Phase 2
Phase 3 |
- Institut Jerome Lejeune
- Fondation Jérôme Lejeune
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Score on a psychomotor development scale after a 6 and 12 months treatment
|
120 |
All |
3 Months to 30 Months (Child) |
NCT00294593 |
IJL-FA-TH01 |
|
October 2000 |
|
December 2003 |
February 22, 2006 |
December 17, 2009 |
|
- Institut Jerome Lejeune
Paris, France
|
|
| 40 |
NCT01920633 |
Completed |
A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832) |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Identification of people with Down syndrome aged 12-30 eligible for upcoming BP27832 study of RG1662
|
135 |
All |
12 Years to 30 Years (Child, Adult) |
NCT01920633 |
BP28947
2013-001264-33 |
|
October 31, 2013 |
January 31, 2015 |
January 31, 2015 |
August 12, 2013 |
July 19, 2017 |
|
- Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States - Emory University School of Medicine; Department of Human Genetics & Pediatrics
Decatur, Georgia, United States - Rush University Medical Center
Chicago, Illinois, United States - (and 19 more...)
|
|
| 41 |
NCT01112683 |
Completed
Has Results |
Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome |
|
- Drug: Memantine
- Drug: Placebo
|
Interventional
|
Phase 4 |
- University of Colorado, Denver
- Forest Laboratories
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in Neuropsychological Measures From Baseline to End of Study
- Changes in Benchmark Neuropsychological Measures From Baseline to End of Study
- Changes of Safety and Tolerability Assessments at Baseline and End of Study
|
42 |
All |
18 Years to 32 Years (Adult) |
NCT01112683 |
06-0934 |
|
July 2008 |
July 2011 |
August 2011 |
April 28, 2010 |
February 1, 2013 |
February 1, 2013 |
- The Children's Hospital
Aurora, Colorado, United States
|
|
| 42 |
NCT03553706 |
Completed |
Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome |
- Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction
|
|
Observational
|
|
- University Hospital of Split
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Categorization of subjects according to norms of growth rates for typical children and children with Down syndrome
- Testing the differences of auxological characteristic according to gestational age
- Auxological characteristics of SGA, AGA and LGA children with DS by norms for DS
|
141 |
All |
up to 1 Month (Child) |
NCT03553706 |
KBC2052018 |
DownSy |
May 20, 2018 |
May 30, 2018 |
May 30, 2018 |
June 12, 2018 |
June 12, 2018 |
|
- Asija Rota Ceprnja
Split, Dalmatia, Croatia
|
|
| 43 |
NCT01436955 |
Completed |
A Study of RG1662 in Individuals With Down Syndrome |
|
- Drug: Placebo
- Drug: RG1662
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety: Incidence of adverse events
- Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests
- Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)
|
35 |
All |
18 Years to 30 Years (Adult) |
NCT01436955 |
BP25543 |
|
November 2011 |
September 2013 |
September 2013 |
September 20, 2011 |
March 3, 2015 |
|
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- (and 6 more...)
|
|
| 44 |
NCT03206957 |
Recruiting |
Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children |
|
- Diagnostic Test: Funduscopic examination and retinal photography
- Diagnostic Test: Serum levels of endostatin and angiogenesis factors
- Diagnostic Test: Renal and low urinary tract Doppler ultrasound
- (and 2 more...)
|
Interventional
|
Not Applicable |
- Queen Fabiola Children's University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Correlation between the number of retinal vessels crossing the optic disc and serum level of endostatin
- Correlation between the number of retinal vessels crossing the optic disc and serum level of other angiogenic factors
- Correlation between serum level of endostatin and serum level of other angiogenic factors
- (and 4 more...)
|
200 |
All |
up to 17 Years (Child) |
NCT03206957 |
P2017/Ophtalmo/DOPANUR |
DOPANUR |
November 30, 2017 |
June 1, 2019 |
June 1, 2019 |
July 2, 2017 |
July 4, 2018 |
|
- Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
|
|
| 45 |
NCT00695695 |
Completed |
The Experience of Caregivers of Children With Down Syndrome |
|
|
Observational
|
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
546 |
All |
18 Years and older (Adult, Older Adult) |
NCT00695695 |
999908142
08-HG-N142 |
|
May 14, 2008 |
|
February 3, 2014 |
June 12, 2008 |
June 19, 2019 |
|
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 46 |
NCT00689988 |
Completed |
Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome |
|
- Behavioral: speech-language therapy with AAC intervention
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Performance on a initial and final lexical assessments, after 12 months of speech-language therapy
- Performance on longitudinal follow-up of twelve months of speech-language therapy with AAC use
|
5 |
All |
5 Years to 11 Years (Child) |
NCT00689988 |
05/1149 |
|
July 2005 |
October 2007 |
June 2008 |
June 4, 2008 |
June 4, 2008 |
|
- University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
São Paulo, SP, Brazil
|
|
| 47 |
NCT01034280 |
Completed |
Correlations Phenotype / Genotype in Down Syndrome |
|
|
Observational
|
|
- Institut Jerome Lejeune
- Fondation Jérôme Lejeune
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
|
524 |
All |
8 Years and older (Child, Adult, Older Adult) |
NCT01034280 |
IJL-PG-EP03
Intrepid |
INTREPID |
March 2004 |
|
May 2011 |
December 17, 2009 |
March 22, 2012 |
|
- Institut Jerome Lejeune
Paris, France
|
|
| 48 |
NCT01148121 |
Completed |
Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model |
|
- Other: Skeletal Status Assessment of a Down Syndrome Population
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Ts65DN pathogenesis proxy
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT01148121 |
113810 |
|
June 2010 |
August 2015 |
August 2015 |
June 22, 2010 |
December 7, 2016 |
|
- University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
|
|
| 49 |
NCT03653143 |
Recruiting |
JASPER Intervention in Down Syndrome |
- Down Syndrome, Trisomy 21
|
|
Interventional
|
Not Applicable |
- Boston Children’s Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in Joint Engagement
- Change in cognition
- Change in language, socialization, problem behavior, adaptive skills (part a)
- (and 5 more...)
|
12 |
All |
36 Months to 48 Months (Child) |
NCT03653143 |
IRB-P00025806 |
|
December 1, 2018 |
December 1, 2019 |
June 1, 2020 |
August 31, 2018 |
January 31, 2019 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
|
| 50 |
NCT00643955 |
Unknown † |
Neuromuscular Characteristics of Individuals With Down Syndrome (DS) |
|
|
Observational
|
|
- State University of New York - Upstate Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Muscle strength Central activation ratio
|
15 |
All |
18 Years to 45 Years (Adult) |
NCT00643955 |
5495 |
|
March 2008 |
|
|
March 26, 2008 |
March 26, 2008 |
|
- IHP
Syracuse, New York, United States
|
|
| 51 |
NCT00643552 |
Completed |
Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome |
|
|
Observational
|
|
- State University of New York - Upstate Medical University
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
|
18 |
All |
17 Years and older (Child, Adult, Older Adult) |
NCT00643552 |
4973 |
|
|
|
|
March 26, 2008 |
March 26, 2008 |
|
|
|
| 52 |
NCT01975545 |
Unknown † |
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 |
|
- Drug: Fluor varnish
- Drug: Fluor varnish with nanoparticles
|
Interventional
|
Phase 2 |
- Universidad Autonoma de San Luis Potosí
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
|
20 |
All |
1 Year to 6 Years (Child) |
NCT01975545 |
MCIC-001 |
|
September 2012 |
April 2014 |
May 2014 |
November 4, 2013 |
March 7, 2014 |
|
- Universidad Autónoma de San Luis Potosí
San Luis Potosí, Mexico
|
|
| 53 |
NCT01256112 |
Completed |
Parent Supported Weight Reduction in Down Syndrome |
|
- Behavioral: Parent Supported Behavioral Intervention
- Behavioral: Nutrition/Activity Education (NAE)
|
Interventional
|
Not Applicable |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Massachusetts, Worcester
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
21 |
All |
13 Years to 26 Years (Child, Adult) |
NCT01256112 |
1 R03 DK070627 (completed)
R03DK070627 |
|
September 2006 |
March 2010 |
March 2010 |
December 8, 2010 |
October 18, 2017 |
|
- Eunice Kennedy Shriver Center at UMASS Medical School
Waltham, Massachusetts, United States
|
|
| 54 |
NCT01791725 |
Completed
Has Results |
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia |
|
- Drug: ELND005
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Transition Therapeutics Ireland Limited
- Elan Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Adverse Events (TEAEs)
|
23 |
All |
18 Years to 45 Years (Adult) |
NCT01791725 |
ELND005-DS201 |
DS201 |
September 2013 |
June 2014 |
June 2014 |
February 15, 2013 |
January 29, 2016 |
January 29, 2016 |
- University of California, San Diego
La Jolla, California, United States - University of California, Irvine
Orange, California, United States - Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 55 |
NCT01821300 |
Active, not recruiting
Has Results |
Down Syndrome Metabolic Health Study |
|
|
Observational
|
|
- Children's Hospital of Philadelphia
- National Institutes of Health (NIH)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Non-HDL Cholesterol
- Lipid Subparticles
- Lipid Subparticles (Size)
- (and 9 more...)
|
257 |
All |
10 Years to 20 Years (Child, Adult) |
NCT01821300 |
12-009233
1R01HD071981-01A1 |
|
February 2013 |
August 25, 2017 |
July 1, 2019 |
April 1, 2013 |
January 31, 2019 |
January 9, 2019 |
- Children's National Medical Center
Washington, District of Columbia, United States - The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 56 |
NCT00951730 |
Completed |
Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome |
|
|
Observational
|
|
- Centre Hospitalier Universitaire de Saint Etienne
- Ministry of Health, France
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Apnea / hypopnea events index determined by reading the complete polysomnography (review reference) and apnea / hypopnoea events index determined by the simplified five parameters of the polysomnography
- Questionnaire on sleep
- Psychometric tests
|
97 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00951730 |
0808017
2008-A01273-52 |
SAOS/T21 |
February 2010 |
February 2015 |
February 2015 |
August 4, 2009 |
July 7, 2015 |
|
- CHU de Grenoble
Grenoble, France - Hospices Civiles de lyon
Lyon, France - CHU de Saint-Etienne
Saint-etienne, France
|
|
| 57 |
NCT01041469 |
Completed |
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome |
- Down Syndrome With and Without Auto Immune Abnormalities
|
|
Observational
|
|
- Institut Jerome Lejeune
- Fondation Jérôme Lejeune
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Auto-antibodies dosage
- specific lymphocytes populations count
|
72 |
All |
8 Years to 36 Years (Child, Adult) |
NCT01041469 |
IJL-IMM-EP10 |
IMMUTRI |
November 2009 |
|
December 2010 |
December 31, 2009 |
March 22, 2012 |
|
- Institut Jerome Lejeune
Paris, France - Laboratoire d'Immunologie Biologique (Unité INSERM U580)
Paris, France
|
|
| 58 |
NCT02996175 |
Completed |
Treatment of Sleep Disturbances in School-age Children With Down Syndrome |
|
- Behavioral: Behavioral Sleep Treatment
- Behavioral: Standard of care sleep treatment enhanced with psychoeducation
|
Interventional
|
Not Applicable |
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
- Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)
- Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).
|
34 |
All |
6 Years to 17 Years (Child) |
NCT02996175 |
1R21HD082307-01A1 |
|
July 2015 |
May 2018 |
May 2018 |
December 19, 2016 |
June 4, 2018 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 59 |
NCT03687619 |
Not yet recruiting |
Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome |
- Down Syndrome, Trisomy 21
|
- Other: CO-OP
- Other: Conductive Education
|
Interventional
|
Not Applicable |
- Hülya Özbeşer
- Eastern Mediterranean University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- performance quality rating scale
- Nine Hole Peg Test
- Bruininks-Oseretsky Motor Proficiency Test - Brief Form
- (and 5 more...)
|
10 |
All |
7 Years to 18 Years (Child, Adult) |
NCT03687619 |
ETK00-218-0213 |
|
February 15, 2019 |
December 15, 2019 |
December 30, 2019 |
September 27, 2018 |
October 16, 2018 |
|
|
|
| 60 |
NCT03551418 |
Recruiting |
Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome |
|
- Behavioral: Watching a video
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Appropriate hand washing technique
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03551418 |
AHC IRB 6884 |
|
June 9, 2018 |
June 9, 2019 |
June 9, 2020 |
June 11, 2018 |
June 28, 2018 |
|
- Adult Down Syndrome Center / Russell Institute for Research and Innovation
Park Ridge, Illinois, United States
|
|
| 61 |
NCT03698539 |
Not yet recruiting |
The Effect of Spontaneous Hand Gestures on Stuttering in Children With Down Syndrome |
|
- Behavioral: hand gestures
|
Observational
|
|
- Universitaire Ziekenhuizen Leuven
- Marguerite-Marie Delacroix
- KU Leuven
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Spontaneous hand gesture frequency
- Stutter frequency
- SMOG frequency
- Partial correlations
|
60 |
All |
6 Years to 14 Years (Child) |
NCT03698539 |
s62049 |
|
November 2018 |
August 2019 |
August 2020 |
October 8, 2018 |
October 9, 2018 |
|
|
|
| 62 |
NCT01394796 |
Completed |
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals. |
|
- Dietary Supplement: Epigallocatechin-3-gallate (EGCG)
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Memory
- DYRK1A activity biomarkers
- Psychomotor speed
- (and 6 more...)
|
31 |
All |
14 Years to 29 Years (Child, Adult) |
NCT01394796 |
EGCG/DYRC1A/DS/IMIM/1 |
|
May 2010 |
February 2011 |
February 2011 |
July 14, 2011 |
March 13, 2013 |
|
|
|
| 63 |
NCT03677245 |
Active, not recruiting |
Balance Bike Training in Down Syndrome |
- Down Syndrome
- Postural Balance
|
- Other: Strider Balance Bike
|
Interventional
|
Not Applicable |
- University of Mississippi Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pediatric Balance Scale (PBS)
- Distance biked
- Change in Participation Level based on the Participation and Environment Measure - Children and Youth (PEM-CY)
- Change in Physical Activity based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report
|
8 |
All |
5 Years to 17 Years (Child) |
NCT03677245 |
2018-0070 |
|
November 26, 2018 |
June 1, 2019 |
June 1, 2019 |
September 19, 2018 |
December 11, 2018 |
|
- University of Mississippi Wellness Center
Flowood, Mississippi, United States
|
|
| 64 |
NCT03764761 |
Recruiting |
Storybook Reading in Individuals With Down Syndrome |
- Down Syndrome
- Augmentative and Alternative Communication
|
- Device: AAC Technology - Standard of Care
- Device: AAC Technology - non-optimal integrated arrangement
|
Interventional
|
Not Applicable |
- Penn State University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- Percent of visual fixation time on meaningful and non meaningful stimuli
- Number of times the participant communicates during the intervention
|
15 |
All |
7 Years to 35 Years (Child, Adult) |
NCT03764761 |
Storybook
R01HD083381-01A1 |
|
April 1, 2018 |
November 30, 2020 |
November 30, 2020 |
December 5, 2018 |
December 5, 2018 |
|
- 11 Ford Building
University Park, Pennsylvania, United States
|
|
| 65 |
NCT01667367 |
Completed |
A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662 |
- Healthy Volunteer, Down Syndrome
|
- Drug: RG1662
- Drug: placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
|
- Brain GABAA receptor alpha5 subunit localization/density assessed by positron emission tomography (PET)
- Brain GABAA receptor alpha5 subunit occupancy following single dose of RG1662
- Correlation of RG1662 plasma concentrations and GABAAalpha5 receptor occupancy
- (and 3 more...)
|
13 |
All |
18 Years to 40 Years (Adult) |
NCT01667367 |
BP25611
2012-001301-24 |
|
August 2012 |
October 2013 |
October 2013 |
August 17, 2012 |
September 2, 2015 |
|
|
|
| 66 |
NCT00675025 |
Terminated |
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial |
|
- Drug: Donepezil Hydrochloride (Aricept)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Physical and neurological exams, clinical labs, ECG, Conmeds, Adverse Events, Serious Adverse Events.
- Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form.
|
128 |
All |
10 Years to 17 Years (Child) |
NCT00675025 |
E2020-A001-220
A2501060 |
|
April 2008 |
February 2009 |
|
May 8, 2008 |
December 11, 2008 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - Child Neurology Associates, PC
Little Rock, Arkansas, United States - Midwest Children's Health Research Institute
Los Angeles, California, United States - (and 28 more...)
|
|
| 67 |
NCT03544840 |
Not yet recruiting |
Investigating Trunk Control in Young Children With Down Syndrome |
- Down Syndrome
- Gross Motor Development Delay
|
- Other: Physical Therapy Home Program
|
Interventional
|
Not Applicable |
- Texas Woman's University
- American Physical Therapy Association
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Segmental Assessment of Trunk Control
- Gross Motor Function Measure
|
20 |
All |
6 Months to 24 Months (Child) |
NCT03544840 |
20067 |
|
June 5, 2018 |
June 5, 2018 |
June 5, 2018 |
June 4, 2018 |
June 4, 2018 |
|
|
|
| 68 |
NCT02158390 |
Completed |
Phenotypic Specific Communication Intervention for Children With Down Syndrome |
- Language Impairment
- Down Syndrome
|
- Behavioral: Jasper-EMT with words and AAC
|
Interventional
|
Not Applicable |
- Vanderbilt University
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Spoken language
- Receptive language
- Executive Functioning
|
78 |
All |
30 Months to 54 Months (Child) |
NCT02158390 |
05302014 |
Merck |
June 2014 |
August 30, 2017 |
February 6, 2018 |
June 6, 2014 |
July 12, 2018 |
|
- University of California, Los Angeles Center for Autism Research and Treatment
Los Angeles, California, United States - Vanderbilt University Kennedy Center
Nashville, Tennessee, United States
|
|
| 69 |
NCT02141971 |
Completed |
Down Syndrome Biomarker Initiative (DSBI) |
- Down Syndrome
- Alzheimer's Disease
|
|
Observational
|
|
- Michael Rafii
- Janssen Research & Development, LLC
- University of California, San Diego
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Rate of decline as measured by cognitive, functional and behavioral tests
- Rate of conversion will be evaluated among all age groups
- Rate of volume change of whole brain, hippocampus, and other structural Magnetic resonance imaging (MRI) measures.
- (and 6 more...)
|
12 |
All |
30 Years to 60 Years (Adult) |
NCT02141971 |
DSBI |
DSBI |
June 1, 2013 |
April 15, 2017 |
April 15, 2017 |
May 20, 2014 |
May 2, 2017 |
|
- University of California, San Diego
La Jolla, California, United States
|
|
| 70 |
NCT03901261 |
Not yet recruiting |
Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21) |
- Down Syndrome
- Alzheimer Disease
|
- Procedure: Neuro-imaging, Lumbar puncture
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Age of onset of Alzheimer's disease
- Gender that could influence the age of onset of the disease as determined by medical record review
- Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review
- (and 18 more...)
|
200 |
All |
35 Years and older (Adult, Older Adult) |
NCT03901261 |
TriAL21 |
|
March 29, 2019 |
March 31, 2023 |
March 31, 2023 |
April 3, 2019 |
April 9, 2019 |
|
- Institut Jérôme Lejeune
Paris, France
|
|
| 71 |
NCT03922165 |
Not yet recruiting |
Healthy Sleep for Children With Down Syndrome |
- Down Syndrome
- Sleep Disordered Breathing
|
- Procedure: Adenotonsillectomy
|
Observational
|
|
- Brigham and Women's Hospital
- Children's Hospital of Philadelphia
- University Hospitals Cleveland Medical Center
- (and 5 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- % enrolled/approached
- % retained/enrolled
|
50 |
All |
3 Years to 13 Years (Child) |
NCT03922165 |
18-015848 |
HELP-DS |
May 1, 2019 |
May 1, 2020 |
August 1, 2020 |
April 19, 2019 |
April 22, 2019 |
|
- University of Michigan Health System
Ann Arbor, Michigan, United States - Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States - University Hospitals-Case Medical Center
Cleveland, Ohio, United States - (and 3 more...)
|
|
| 72 |
NCT01832753 |
Active, not recruiting
Has Results |
Treatment Trial of Subclinical Hypothyroidism in Down Syndrome |
- Down Syndrome
- Subclinical Hypothyroidism
|
|
Interventional
|
Not Applicable |
- Children's Hospital of Philadelphia
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Change in Lipid Panel From Baseline at 6, 12 and 18 Months.
- Change in Quality of Life From Baseline at 6, 12 and 18 Months.
|
12 |
All |
8 Years to 20 Years (Child, Adult) |
NCT01832753 |
12-009578
1R01HD071981-01A1 |
|
January 2013 |
October 18, 2017 |
July 1, 2019 |
April 16, 2013 |
June 13, 2019 |
June 13, 2019 |
- Children's National Medical Center
Washington, District of Columbia, United States - The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 73 |
NCT00864461 |
Completed |
Frequency of Metabolic Syndrome in Down Syndrome Patients |
- Metabolic Syndrome X
- Down Syndrome
|
|
Observational
|
|
- Universidad de Guanajuato
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo.
- Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods.
|
96 |
All |
7 Years to 24 Years (Child, Adult) |
NCT00864461 |
249-08 |
|
September 1, 2009 |
December 21, 2009 |
March 31, 2010 |
March 18, 2009 |
May 5, 2017 |
|
- School of Medicine, University of Guanajuato
Leon, Guanajuato, Mexico
|
|
| 74 |
NCT03771469 |
Recruiting |
Validation of Sleep Questionnaires in the Down Syndrome Population |
- Obstructive Sleep Apnea
- Down Syndrome
|
- Diagnostic Test: Sleep study
|
Interventional
|
Not Applicable |
- Oregon Health and Science University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Apnea-hypopnea index (AHI) from polysomnography
- Sleep Related Breathing Disorder subscale total of the Pediatric Sleep Questionnaire (SRBD-PSQ)
- Sleep-Related Quality of Life (OSA-18 total score)
- Generic Quality of Life
|
60 |
All |
2 Years to 17 Years (Child) |
NCT03771469 |
STUDY00018522
GOTOL0341A |
|
June 25, 2018 |
September 2019 |
April 2020 |
December 11, 2018 |
December 12, 2018 |
|
- Doernbecher Children's Hospital
Portland, Oregon, United States
|
|
| 75 |
NCT02859389 |
Recruiting |
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome |
|
|
Observational
|
|
- St. Jude Children's Research Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Neurocognitive Outcome
- Psychosocial Outcome
|
80 |
All |
Child, Adult, Older Adult |
NCT02859389 |
DSCOG |
|
August 18, 2016 |
August 2019 |
August 2019 |
August 9, 2016 |
September 11, 2018 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
|
| 76 |
NCT03084497 |
Completed |
Effects of Infant Massage on Development of Down Syndrome Babies |
|
- Procedure: Infant Massage
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Developmental Age
- Change from Developmental coefficient
|
32 |
All |
4 Months to 8 Months (Child) |
NCT03084497 |
USeville - EPinto |
|
August 2016 |
September 2016 |
October 2016 |
March 21, 2017 |
March 21, 2017 |
|
- University of Seville
Sevilla, Spain
|
|
| 77 |
NCT01778946 |
Recruiting |
Nicotine Treatment of Cognitive Decline in Down Syndrome |
- Down Syndrome
- Mild Cognitive Impairment
|
- Drug: Low Dose Nicotine (7mg)
- Drug: Moderate Dose Nicotine (14mg)
|
Interventional
|
Phase 1
Phase 2 |
- Vanderbilt University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of Nicotine Intervention
- Cognitive Improvement
- Exploratory
|
15 |
All |
25 Years and older (Adult, Older Adult) |
NCT01778946 |
121759 |
|
April 2013 |
December 2019 |
December 2019 |
January 29, 2013 |
May 20, 2019 |
|
- Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
|
|
| 78 |
NCT03778528 |
Recruiting |
Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome |
|
- Procedure: cataract surgery
|
Observational
|
|
- University of Colorado, Denver
- Children's Hospital Colorado
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in protein composition
|
20 |
All |
1 Month to 18 Years (Child, Adult) |
NCT03778528 |
17-0372 |
|
May 30, 2018 |
May 2020 |
June 2020 |
December 18, 2018 |
December 18, 2018 |
|
- Children's Hospital of Colorado
Aurora, Colorado, United States
|
|
| 79 |
NCT02304302 |
Recruiting |
Down Syndrome Memantine Follow-up Study |
- Down Syndrome
- Intellectual Disability
|
- Drug: Memantine
- Drug: Placebo
|
Interventional
|
Phase 2 |
- University Hospitals Cleveland Medical Center
- Alana USA Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy of the drug Memantine as assessed by the California Verbal Learning Test-II (CVLT-II) short form
- Efficacy of the drug Memantine as assessed by Paired Associates Learning (PAL) from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Efficacy of the drug Memantine as assessed by Recall of Digits (Differential Ability Scales; DAS-II).
- (and 5 more...)
|
200 |
All |
15 Years to 32 Years (Child, Adult) |
NCT02304302 |
121971 |
|
October 2014 |
November 2019 |
December 2019 |
December 1, 2014 |
October 10, 2018 |
|
- University Hospitals Case Medical Center
Cleveland, Ohio, United States - Sociedade Beneficente Israelita Brasileira Albert Einstein
São Paulo, SP, Brazil
|
|
| 80 |
NCT02971254 |
Recruiting |
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients |
|
- Drug: Sevoflurane
- Drug: Desflurane
|
Interventional
|
Phase 2 |
- Asklepieion Voulas General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Supportive Care
|
- Change in Cognitive Functions
- Spontaneous breathing
- Eye opening
- (and 10 more...)
|
39 |
All |
16 Years to 75 Years (Child, Adult, Older Adult) |
NCT02971254 |
8174/24.04.2013 |
|
April 2013 |
November 2017 |
|
November 22, 2016 |
July 19, 2017 |
|
- Gkliatis Emmanouil
Athens, Greece
|
|
| 81 |
NCT00959283 |
Active, not recruiting |
Study of Blood Samples From Newborns With Down Syndrome |
- Myeloid Proliferations Associated With Down Syndrome
|
- Other: Diagnostic Laboratory Biomarker Analysis
- Other: Pharmacological Study
|
Observational
|
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
|
- Event-free survival
- Overall survival
- Incidence of TMD-related mortality
- Incidence of subsequent leukemia for patients with resolved TMD
|
180 |
All |
up to 90 Days (Child) |
NCT00959283 |
AAML08B1
NCI-2011-02193
CDR0000636115
COG-AAML08B1
U10CA098543
UG1CA189958 |
|
February 23, 2009 |
December 30, 2011 |
|
August 14, 2009 |
August 7, 2018 |
|
- Children's Hospital of Alabama
Birmingham, Alabama, United States - University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States - University of South Alabama
Mobile, Alabama, United States - (and 186 more...)
|
|
| 82 |
NCT00754052 |
Terminated
Has Results |
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 |
- Down Syndrome
- Cognitive Dysfunction
|
- Drug: Aricept (donepezil hydrochloride)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)
- Mean Change From Baseline in Additional Analyses of the VABS-11/PCRF
- Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER)
- Mean Change From Baseline if the Forward Memory and Attention Sustained Sub-tests of the Leiter International Performance Scale - Revised (Leiter-R)
|
8 |
All |
11 Years to 17 Years (Child) |
NCT00754052 |
E2020-A001-335
A2501061 |
|
September 2008 |
November 2008 |
December 2008 |
September 17, 2008 |
April 23, 2018 |
April 23, 2018 |
- Road Runner Research
San Antonio, Texas, United States - Neuroscience, Inc
Herndon, Virginia, United States
|
|
| 83 |
NCT02651493 |
Recruiting |
Digital Dysmorphology Project |
|
|
Interventional
|
Not Applicable |
- Kevin Cleary
- Children's Research Institute
- George Washington University
- Chiang Mai University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Number of participants with Down syndrome accurately assessed by computer-aided detection (CADe) tool
- Number of participants with other dysmorphic syndromes accurately assessed by computer-aided detection (CADe) tool
|
750 |
All |
up to 18 Years (Child, Adult) |
NCT02651493 |
Pro00003506. |
|
February 2013 |
December 2023 |
December 2023 |
January 11, 2016 |
January 4, 2019 |
|
- Children's National
Washington, District of Columbia, United States
|
|
| 84 |
NCT00287417 |
Completed |
Early Ultrasound and Maternal Biochemical Markers to Evaluate the Risk of Down Syndrome During the First Trimester |
|
- Device: echography
- Other: blood sample
|
Observational
|
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
20000 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00287417 |
3032 |
|
July 2003 |
|
February 2011 |
February 6, 2006 |
May 16, 2011 |
|
- Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France - Service de Gynécologie-Obstétrique, SIHCUS, CMCO
Strasbourg, Alsace, France - Centre Hospitalier
Belfort, France - (and 4 more...)
|
|
| 85 |
NCT01684670 |
Completed |
Intensive Dysarthria Sessions in Adults and Children With Down Syndrome |
|
- Behavioral: Speech sessions
|
Interventional
|
Not Applicable |
- Duke University
- University of Rhode Island
- University of Florida
- University of North Carolina, Chapel Hill
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
5 |
All |
8 Years and older (Child, Adult, Older Adult) |
NCT01684670 |
Pro00039730 |
|
February 2014 |
May 2016 |
May 2016 |
September 13, 2012 |
November 23, 2016 |
|
- Duke University Health System
Durham, North Carolina, United States
|
|
| 86 |
NCT00056329 |
Unknown † |
Vitamin E in Aging Persons With Down Syndrome |
- Down Syndrome
- Alzheimer Disease
|
- Drug: Vitamin E
- Drug: multivitamin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- New York State Institute for Basic Research
- National Institute on Aging (NIA)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Center for Complementary and Integrative Health (NCCIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements
- Fuld Object Memory Test (Modified), New Dot Test, Orientation Test, Vocabulary Test, Behavior & Function Down Syndrome Rating Scale, Clinical Global Impression of Change (CGI-C)
|
350 |
All |
50 Years and older (Adult, Older Adult) |
NCT00056329 |
IA0039
R01AG016381
NIA Grant AG16381 |
|
April 2002 |
May 2012 |
May 2012 |
March 12, 2003 |
May 4, 2012 |
|
- University of Connecticut Health Center
Farmington, Connecticut, United States - Roskamp Institute Memory Clinic
Tampa, Florida, United States - Institute for the Study of Disadvantage and Disability
Atlanta, Georgia, United States - (and 19 more...)
|
|
| 87 |
NCT00754013 |
Terminated
Has Results |
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 |
- Down Syndrome
- Cognitive Dysfunction
|
- Drug: Aricept (Donepezil hydrochloride)
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.
- Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.
|
9 |
All |
6 Years to 10 Years (Child) |
NCT00754013 |
E2020-A001-336
A2501061 |
|
September 2008 |
October 2008 |
December 2008 |
September 17, 2008 |
March 21, 2017 |
February 13, 2013 |
- Road Runner Research
San Antonio, Texas, United States - NeuroScience, Inc.
Herndon, Virginia, United States
|
|
| 88 |
NCT01580384 |
Completed |
A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Neurocognitive batteries/tests/scales: Suitability for individuals with Down syndrome assessed by number of tests completed/subjects completing, ceiling/floor effect, variance estimate of baseline/change from baseline
- Test/re-test reliability: Changes in test results over 4 weeks
- Changes in test results over 6 month interval
- Correlations between test results on functioning, adaptive behavior and cognition and IQ level
|
90 |
All |
12 Years to 30 Years (Child, Adult) |
NCT01580384 |
BP25612 |
|
February 2012 |
January 2014 |
January 2014 |
April 19, 2012 |
March 3, 2015 |
|
- Tucson, Arizona, United States
- Durham, North Carolina, United States
- Ciudad Autonoma de Bs As, Argentina
- (and 9 more...)
|
|
| 89 |
NCT01808508 |
Completed
Has Results |
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome |
- Down Syndrome
- Obstructive Sleep Apnea Syndrome
|
- Device: Continuous positive airway pressure
- Device: Sham or placebo continuous positive airway pressure
|
Interventional
|
Not Applicable |
- Children's Hospital of Philadelphia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Epworth Sleepiness Scale From Baseline to End of Study
- Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months
- Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months
- Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months
|
27 |
All |
8 Years to 20 Years (Child, Adult) |
NCT01808508 |
11-007964 |
TRIO |
September 2010 |
March 2014 |
September 2014 |
March 11, 2013 |
February 8, 2016 |
February 8, 2016 |
- The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 90 |
NCT02759887 |
Unknown † |
Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD) |
- Down Syndrome
- Alzheimer's Dementia
|
- Procedure: biospecimen collection
- Other: cognitive assessments
- Other: caregiver questionnaire
- (and 5 more...)
|
Interventional
|
Not Applicable |
- St. Joseph's Hospital and Medical Center, Phoenix
- Banner Alzheimer's Institute, Phoenix
- Translational Genomics Research Institute (TGEN), Phoenix
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Florbetapir PET - change between timeframes
- tau PET - change between timeframes
- FDG PET - change between timeframes
- (and 2 more...)
|
40 |
All |
21 Years and older (Adult, Older Adult) |
NCT02759887 |
PHX-16-0028-70-03 |
|
November 2016 |
March 2019 |
June 2019 |
May 3, 2016 |
November 3, 2016 |
|
- St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
|
|
| 91 |
NCT01902407 |
Enrolling by invitation |
Computer Models of Airways in Children and Young Adults With Sleep Apnea and Down Syndrome |
- Down Syndrome
- Obstructive Sleep Apnea
|
|
Observational
|
|
- Children's Hospital Medical Center, Cincinnati
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Measurement of critical closing pressure of the airway-Sleep MRI
|
73 |
All |
1 Year to 90 Years (Child, Adult, Older Adult) |
NCT01902407 |
CIN001-Dymosa
R01HL105206-01 |
DYMOSA |
March 2011 |
December 2027 |
December 2027 |
July 18, 2013 |
July 24, 2018 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 92 |
NCT03687866 |
Active, not recruiting |
Non-invasive Screening of Fetal Trisomy 21 by Digital PCR |
|
- Genetic: non invasive prenatal testing
|
Observational
|
|
- University Hospital, Caen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- feasibility of non invasive prenatal testing with digital PCR
|
776 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03687866 |
14-048 |
dPNI-T21 |
January 2013 |
September 2015 |
December 2018 |
September 27, 2018 |
September 27, 2018 |
|
|
|
| 93 |
NCT00394290 |
Completed |
Down Syndrome and Continuous Positive Pressure Therapy |
- Down Syndrome
- Obstructive Sleep Apnea Syndrome
|
- Device: Continuous Positive Pressure
|
Interventional
|
Not Applicable |
- Institut Jerome Lejeune
- Fondation Jérôme Lejeune
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
- Tolerability
|
31 |
All |
18 Years and older (Adult, Older Adult) |
NCT00394290 |
IJL-PPC-EP02
Morphee |
Morphee |
November 16, 2006 |
October 31, 2012 |
December 31, 2012 |
November 1, 2006 |
March 26, 2019 |
|
- Institut Jerome Lejeune
Paris, France
|
|
| 94 |
NCT03210675 |
Recruiting |
Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome |
- Down Syndrome
- Obstructive Sleep Apnea of Newborn
|
- Diagnostic Test: Polysomnography (PSG)
|
Interventional
|
Not Applicable |
- Institut Jerome Lejeune
- Hôpital Necker-Enfants Malades
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Mean Griffith Mental Development Scale (GMDS) scores
|
80 |
All |
6 Months to 3 Years (Child) |
NCT03210675 |
DP-TRS-T21 |
RESPIRE21 |
July 31, 2017 |
December 2022 |
December 2022 |
July 7, 2017 |
March 7, 2018 |
|
- Institut Jérome Lejeune
Paris, France
|
|
| 95 |
NCT00965835 |
Unknown † |
Amyloid Plaque and Tangle Imaging in Alzheimer's Disease and Down Syndrome |
- Down Syndrome
- Alzheimer's Disease
|
|
Observational
|
|
- National Institute on Aging (NIA)
|
NIH |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
40 |
All |
21 Years and older (Adult, Older Adult) |
NCT00965835 |
IA0166
1R21AG030681-01A2 |
|
August 2009 |
May 2011 |
May 2011 |
August 26, 2009 |
December 29, 2009 |
|
- UCLA
Los Angeles, California, United States
|
|
| 96 |
NCT00966017 |
Unknown † |
Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia |
- Down Syndrome
- Alzheimer's Disease
|
|
Observational
|
|
- National Institute on Aging (NIA)
|
NIH |
- Observational Model: Case Control
- Time Perspective: Retrospective
|
|
108 |
All |
45 Years and older (Adult, Older Adult) |
NCT00966017 |
IA0167
1R01AG033015-01 |
|
July 2009 |
February 2014 |
February 2014 |
August 26, 2009 |
December 29, 2009 |
|
- UCLA
Los Angeles, California, United States
|
|
| 97 |
NCT01725438 |
Active, not recruiting |
Non Invasive Prenatal Diagnosis of Trisomy 21 by Genetic Analysis of Circulating Fetal Cells |
|
|
Interventional
|
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
- Institut National de la Santé Et de la Recherche Médicale, France
- Rarecells
- University of Paris 5 - Rene Descartes
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- non-invasive method of PND of Trisomy 21.
|
150 |
All |
18 Years and older (Adult, Older Adult) |
NCT01725438 |
AOM10123
P100118 |
ISETTRI21 |
June 19, 2012 |
March 31, 2017 |
December 31, 2017 |
November 12, 2012 |
December 8, 2017 |
|
- Hopital de Béclère
Clamart, France
|
|
| 98 |
NCT00877292 |
Completed |
A New Prenatal Blood Test for Down Syndrome |
|
|
Observational
|
|
- Women and Infants Hospital of Rhode Island
- Sequenom, Inc.
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy.
- The secondary aim is to develop a sample bank to allow documentation of subsequent improvements in the existing LDT or documenting performance of new methodologies.
|
4664 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00877292 |
09-0004 |
RNA |
February 2009 |
January 2011 |
May 2011 |
April 7, 2009 |
June 3, 2015 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Yale University School of Medicine
New Haven, Connecticut, United States - (and 24 more...)
|
|
| 99 |
NCT02344108 |
Recruiting |
A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea |
- Sleep Apnea, Obstructive
- Down Syndrome
|
- Device: Inspire® Upper Airway Simulation System (Model 3028 IPG )
|
Interventional
|
Not Applicable |
- Christopher Hartnick, M.D.
- Massachusetts General Hospital
- University Hospitals Cleveland Medical Center
- (and 13 more...)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess the safety and efficacy of hypoglossal nerve stimulator placement for the treatment of obstructive sleep apnea in adolescents with Down Syndrome.
- Efficacy of implantation in adolescents and young adults with Down syndrome (Sleep questionnaires)
|
50 |
All |
10 Years to 21 Years (Child, Adult) |
NCT02344108 |
14-146H |
|
February 2015 |
June 30, 2019 |
September 30, 2020 |
January 22, 2015 |
December 6, 2018 |
|
- Stanford Children's Hospital/Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States - Henrietta Egleston Hospital for Children
Atlanta, Georgia, United States - Massachusetts Eye and Ear
Boston, Massachusetts, United States - (and 10 more...)
|
|
| 100 |
NCT00378456 |
Completed |
Vitamins and Minerals for Children With Downs Syndrome |
- Trisiomy 21 (Down Syndrome)
|
- Drug: Antioxidants- (Vitamins A,C,E Selenium and Zinc)
- Drug: Folinic acid
- Drug: Vitamins A,C,E Selenium and Zinc and Folinic acid.
- Drug: Placebo
|
Interventional
|
Not Applicable |
- Institute of Child Health
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
|
|
|
All |
up to 7 Months (Child) |
NCT00378456 |
98CH11 |
|
|
|
|
September 20, 2006 |
September 20, 2006 |
|
- Institute of Child Health
Birmingham, United Kingdom - Peninsular Medical School
Exeter, United Kingdom - Institute of Child Health, London
London, United Kingdom
|
|
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