Trial-Ready Cohort-Down Syndrome (TRC-DS) (TRC-DS)
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|ClinicalTrials.gov Identifier: NCT04165109|
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment|
|Down Syndrome Alzheimer Disease Dementia||Radiation: Flutafuranol Radiation: Pittsburgh Compound (PIB) Radiation: MK6240|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)|
|Actual Study Start Date :||June 7, 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Trial Ready Cohort
Non-demented adults with Down syndrome (DS)
All participants at qualifying sites will receive a single bolus intravenous injection of 8.1 mCi (300 MBq) (+/- 20%, 10μg mass dose) of flutafuranol ([18F]NAV4694). At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Radiation: Pittsburgh Compound (PIB)
All participants at qualifying sites will receive a single bolus intravenous injection of 15 mCi (555 MBq) (± 10%) of PIB. At approximately 30-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
All participants at qualifying sites will receive a single bolus intravenous injection of 5 mCi (185 MBq) (± 20%) of MK6240. At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Other Name: [18F]MK-6240
- Enrollment of 120 participants into the Trial-Ready Cohort in DS (TRC-DS). [ Time Frame: 5 years ]The primary aim of the TRC-DS is enrollment of 120 participants into the trial ready cohort to support future referral and enrollment into primary Alzheimer's disease (AD) prevention trials for adults with DS.
- Change in cognition as measured by the Cued Recall Test [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]The Cued Recall Test is modified from a version developed for adults from the typical population. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled. Two scores are generated from the test, a Free Recall Score and a Total Score (Free Recall plus items recalled when the category cue is provided). A cut-off of < 23 on the Total Score resulted in a sensitivity of 91% and a specificity of 84% when individuals with DS and a diagnosis of dementia were compared to their healthy peers without dementia.
- Change in behavior as measured by the Neuropsychiatric Inventory (NPI) [ Time Frame: Screening and Month 16, or until enrollment into a clinical trial ]The Neuropsychiatric Inventory (NPI) is a well-validated, reliable, multi-item instrument to assess psychopathology in AD based on an interview with a caregiver or qualified study partner. It evaluates both the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite and eating disorders. A higher NPI score means that the participant is displaying more behavioral symptoms. The minimum score is 0 and the maximum is 144. A score of 0-20 is mild, 20-50 moderate and greater than 50 means significant behavioral symptoms.
- Change in cognition as measured by the Down Syndrome Mental Status Exam (DSMSE) [ Time Frame: Screening and Month 16, or until enrollment into a clinical trial ]The DSMSE is an omnibus measure of neuropsychological function that assesses a broad range of skills and is easy to administer. It is divided into items that test recall for personal information, orientation to season and day of week, memory, language, visuospatial function, and praxis. Recall for personal information is tested with questions about the subject's name, age and birth date. Orientation items ask the day of the week and season of the year. Memory in the DSMSE is assessed with items that require immediate and delayed recall of three objects and for the location of three hidden objects. Language items include confrontation naming, sentence repetition, and comprehension of one, two, and three step commands. Visuospatial items are three-dimensional block constructions. Praxis items include transitive and intransitive limb movements and a sequential task.
- Change in behavior as measured by the Vineland 3 (Informant Version) [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]
The Vineland Adaptive Behavior Scale 3 (VABS-II) I is a normed assessment tool that assesses adaptive behavior across the areas of communication, activities of daily living, and socialization. The tool is self-administered via interview toby a study partner using a tablet (e.g. iPad), takes approximately 45 minutes to complete and may be done remotely.
The VABS-III scores range from 20-140. Higher scores indicate higher functioning. Specifically, these include 'very high' (domain and Adaptive Behavior Scale (ABC) Standard Scores of 130-140), "moderately high" (domain and ABC Standard Scores of 115-129), "adequate" (domain and ABC Standard Scores of 86-114), "moderately low" (domain and ABC Standard Scores of 71-85), and "low" (domain and ABC Standard Scores of 20-70).
- Change in cognition as measured by the National Task Group Early Detection Screen for Dementia (NTG-EDSD) [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]The National Task Group Early Detection Screen for Dementia (NTG-EDSD) is a screening tool which measures changes typically observed in dementia. It is composed of four primary sections about relative demographics, ratings of health, mental health, and life stressors, a review of multiple domains associated with adult functioning, and a review of chronic medical conditions. The NTG-EDSD is completed by a staff member who interviews the caregiver. It contains 40 questions/question groups and takes 15 mins to administer.
- Change in cognition as measured by the Stroop Dog and Cat Task [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]In the Stroop Dog and Cat Task, a linear sequence of 16 pictures (8 cats, 8 dogs) are presented in a pre-determined random order. In the control condition the subject says the name of each picture and is urged to do so rapidly. In the experimental (inhibition) condition the participant is required to say 'cat' for the picture of each dog and 'dog' for the cat. For each condition the participant is given a brief practice period. Performance on the Stroop Dog and Cat was significantly related to informant-reported memory changes in 103 adults with DS with mild-moderate intellectual disability in the age range of 36 - 72 years.
- Change in amyloid deposition as measured by SUVR on Positron Imaging Tomography (PET) scan [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]
- Change in brain volume as measured by magnetic resonance imaging (MRI) [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]
- Change in plasma Amyloid Beta (Abeta) biomarkers [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]
- Change in plasma tau biomarkers [ Time Frame: Baseline and Month 16, or until enrollment into a clinical trial ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165109
|Contact: ATRI Recruitment Teamfirstname.lastname@example.org|
|United States, Arizona|
|Barrow Neurological Institute||Not yet recruiting|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|University of California, Irvine School of Medicine||Not yet recruiting|
|Orange, California, United States, 92868|
|United States, Colorado|
|Linda Crnic Institute for Down Syndrome, University of Colorado||Not yet recruiting|
|Aurora, Colorado, United States, 80045|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Katherine Britt 317-963-7427 email@example.com|
|Principal Investigator: Jill Fodstad, PhD|
|United States, Kentucky|
|University of Kentucky||Not yet recruiting|
|Lexington, Kentucky, United States, 40504|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|Washington University, St. Louis||Not yet recruiting|
|Saint Louis, Missouri, United States, 63108|
|United States, New York|
|New York State Institute for Basic Research in Developmental Disabilities (SIBRDD)||Not yet recruiting|
|Staten Island, New York, United States, 10314|
|United States, Ohio|
|Case Western Reserve University||Not yet recruiting|
|Beachwood, Ohio, United States, 44122|
|United States, Pennsylvania|
|University of Pittsburgh||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Vanderbilt University Medical Center Center for Cognitive Medicine||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Amy Boegel, Dr. 615-875-0955 firstname.lastname@example.org|
|Principal Investigator: Paul Newhouse, Dr.|
|Sant Pau Biomedical Research Institute (IIB Sant Pau)||Not yet recruiting|
|Barcelona, Spain, 08041|
|University of Cambridge||Not yet recruiting|
|Cambridge, United Kingdom, CB2 1TN|
|King's College London, Institute of Psychiatry, Psychology & Neuroscience||Not yet recruiting|
|London, United Kingdom, SE5 8AF|
|Principal Investigator:||Michael Rafii, MD, PhD||USC Alzheimer's Therapeutic Research Institute (ATRI)|