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Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)

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ClinicalTrials.gov Identifier: NCT03901261
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Jerome Lejeune

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date April 9, 2019
Estimated Study Start Date  ICMJE March 29, 2019
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Age of onset of Alzheimer's disease [ Time Frame: 2 years ]
    age (year)
  • Gender that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Level of intellectual diasability that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Family history of Alzheimer's disease that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Cardio-vascular risk factors that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Down syndrome comorbidies that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Genetic's factor other than APP that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Head trauma that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
  • Age of menopause that could influence the age of onset of the disease as determined by medical record review [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03901261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2019)
  • Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living (Katz ADL) score [ Time Frame: 2 years ]
    Questionnaire about Activities of Daily Living such as bathing, toileting, continence, dressing, transferring and feeding Scoring : Independence: 1 point - Partial dependence 0.5 point - Full dependence: 0 point
  • Evaluation of neuropsychological evolution using Lawton-Brody Instrumental Activities of Daily Living scale ( IADL) [ Time Frame: 2 years ]
    Questionnaire about strumental Activities of Daily Living such as ability to use telephone, responsibility for taking medication, travels independently on public transportation, ability to handle finances Scoring : 0 or 1
  • Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) score [ Time Frame: 2 years ]
    Dementia Screening for Individuals with Intellectual Disabilities Questionnary is a autonomy and psychobeahavioral questionnaire to gather information from carers of people with Down's syndrome about the symptoms of dementia
  • Evaluation of neuropsychological evolution using Cambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score [ Time Frame: 2 years ]
    Camdex-Ds. Based on an informant interview to aid the diagnosis of dementia in people with DS according to the DSM-IV et ICD criteria for dementia.
  • Evaluation of neuropsychological evolution using Cambridge Cognition Examination score [ Time Frame: 2 years ]
    It is part of the CAMDEX-DS. Section 2 involves the direct assessment of patient. It contains seven different subscales and has 46 items. it gives a total score of 108. Decline between assessment at Time 1 and assessment at time 2 in association with CAMDEX confirm or evoque the AD diagnosis.
  • Evaluation of neuropsychological evolution using Cued Recall test score [ Time Frame: 2 years ]
    It is a memory task. It consists in 12 items accompanied by a unique category cue, presented four a time in three trials. It generates two measures respectively for learning phase and delayed recall: a free recall score/12 and a total score/36 (FRS plus items recalled with cue) for the learnig phase. A free recall (FRS/12) and a total score (FRS plus items recalled with cue /12) for the delayed recall. Number of intrusions will be also recorded.
  • Evaluation of neuropsychological evolution using Cancellation task [ Time Frame: 2 years ]
    Measure of task accuracy (total number of correct responses, range score 0-16) and total time performance (in seconds) were included in the analyses.
  • Evaluation of neuropsychological evolution using Leiter III assessment score [ Time Frame: 2 years ]
    It is a nonverbal measure of intelligence & cognitive abilities. It includes four subtests whose raw scores are converted to normalised scaled scores (mean [M] = 10, standard deviation [SD] = 3). It gives an IQ standard score (M = 100; SD = 15).
  • Identification of prodromal Alzheimer's disease markers using brain imaging [ Time Frame: 2 years ]
    Whole brain volumetry calculation, hippocampus volume calculation, white matter lesions volumetry calculation
  • Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid [ Time Frame: 2 years ]
    1-40 beta-amyloid, 1-42 beta-amyloid, tau, phosphorylated tau
  • Number of adverse event and serious adverse events related to trial procedures [ Time Frame: 2 years ]
    Adverse events graded 3-4-5 according to CTCAE v5.0
  • Evaluation of survival assessed by vital status [ Time Frame: 2 years ]
    Date and cause of death
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Evaluation of neuropsychological evolution using Katz Index of Independence in Activities of Daily Living score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Dementia Screening Questionnaire for Individuals with Intellectual Disabilities score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Lawton-Brody instrumental activities of daily living scale score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using DCambridge Examination for Mental Disorders of Older People with Down's Syndrome and Others with Intellectual Disabilities score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Cambridge Cognition Examination score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Cued Recall test score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Cancellation test score [ Time Frame: 2 years ]
  • Evaluation of neuropsychological evolution using Leiter III assessment score [ Time Frame: 2 years ]
  • Identification of prodromal Alzheimer's disease markers using brain imaging [ Time Frame: 2 years ]
    Whole brain volumetry calculation, hippocampus volume calculation, white matter lesions volumetry calculation
  • Identification of prodromal Alzheimer's disease markers using dosage (pg/mL) of biomarkers in cerebrospinal fluid [ Time Frame: 2 years ]
    1-40 beta-amyloid, 1-42 beta-amyloid, tau, phosphorylated tau
  • Number of adverse event and serious adverse events related to trial procedures [ Time Frame: 2 years ]
    Adverse events graded 3-4-5 according to CTCAE v5.0
  • Evaluation of survival assessed by vital status [ Time Frame: 2 years ]
    Date and cause of death
  • Medical data used to establish diagnosis of Alzheimer disease in case of onset during the study [ Time Frame: 2 years ]
    Clinical data collection Neuropsychological data collection Brain imaging data collection Blood and cerebrospinal biomarkers dosage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)
Official Title  ICMJE Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease
Brief Summary

TriAL21 study is an interventional, open, one arm, prospective, national and single center study.

A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.

Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.

Detailed Description

The aim of the study is to describe and follow a cohort of patients with Down syndrome without diagnosis of Alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease.

The total study duration will be approximately 4 years.

  • Inclusion period : 2 years
  • Follow-up period per patient : 2 years

Patients will be then followed during 10 years for routine medical follow-up. In case of Alzheimer's disease onset during this period, all data regarding diagnosis of AD will be collected for the study. Data about dementia evolution and mortality in case of AD diagnosis during the study will also be collected during this follow-up period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Interventional prospective monocentric, national open study with single arm
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Down Syndrome
  • Alzheimer Disease
Intervention  ICMJE Procedure: Neuro-imaging, Lumbar puncture
Optional Lumbar Puncture will be performed at inclusion visit Optional Neuro-Imaging (MRI (Magnetic Resonance Imaging) will be performed within 3 months after inclusion visit
Study Arms  ICMJE Experimental: Down syndrome patients
Intervention: Procedure: Neuro-imaging, Lumbar puncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 35 years old and over ;
  • Clinical diagnosis of Down syndrome ;
  • Patient attending the geriatric outpatient clinic
  • Patient without diagnosis of Alzheimer's disease;
  • Patient covered by social welfare;
  • Patient himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent;
  • Patients must have a parent, or / and other reliable caregiver who agrees to accompany him/her to all visits, provide information about the patient as required by the protocol. The parent or caregiver must be a constant and reliable informant with sufficient contact with the patient to have detailed knowledge of the patient's adaptive functioning in order to be able to complete the assessments accurately.

Exclusion Criteria:

  • Patient presenting a contraindication to MRI in particular carrier of metal implants such as pacemakers;
  • Patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters;
  • Patient without Alzheimer's disease diagnosis but with severe dementia;
  • Participation in other clinical trials in the last 3 months prior to the study;
  • Pregnant woman.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne-Sophie REBILLAT, MD, PhD +33 1 56 58 63 00 annesophie.rebillat@institutlejeune.org
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901261
Other Study ID Numbers  ICMJE TriAL21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Jerome Lejeune
Study Sponsor  ICMJE Institut Jerome Lejeune
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Jerome Lejeune
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP