Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD) (NCT02759887) | Clinical Trial Compass
CompletedNot Applicable
Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD)
United States19 participantsStarted 2016-11
Plain-language summary
In order to treat individuals with Down syndrome (DS) better and more efficiently and to gain more insights on its relation to Alzheimer's disease (AD), a comprehensive understanding is needed for its progression in the early or preclinical phase using various biomarkers. DS is a significant risk factor for the early development of AD, with plaques and tangles typically developing by age 35. A better understanding is needed of early markers of the disease in DS patients. Additionally the DS population represents a unique group - due to this elevated risk for AD - to examine biomarkers that may translate in general outside of the DS population to individuals at risk for developing late onset AD. In this proposal, the researchers will assess the longitudinal changes of various biomarkers in a cohort of individuals similar in design to the cross-sectional sectional study in the preliminary data.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for Non-AD/DS subjects:
* Subjects with free Trisomy 21.
* Male or female subjects who are 21 years of age or older.
* Subjects who are not diagnosed with possible or probable AD or dementia after evaluation NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke- Alzheimer's Disease and Related Disorders Association) criteria.
* Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status.
* If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (subject must still confirm assent).
Inclusion criteria for AD/DS subjects:
* Subjects with free Trisomy 21.
* Male or female subjects who are 40 and older years of age.
* Subjects who are diagnosed with possible or probable using NINCDS-ADRDA criteria.
* Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status.
* If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (subject must still confirm assent).
Inclusion criteria for Normal Controls
* Cognitively normal, non-DS individuals.
* Age-matched to the DS group.
* Subjects who signed an Institutional Review Board-approved informed consent.
Exclusion Criteria: (for all groups)
* Previous or current diagnosis of a neurodegenerative disorders other than AD or D…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Florbetapir PET - change between timeframes
Timeframe: Year 1, Year 2-3
2
tau PET - change between timeframes
Timeframe: Year 1, Year 2-3
3
FDG PET - change between timeframes
Timeframe: Year 1, Year 2-3
4
MRI - change between timeframes
Timeframe: Year 1, Year 2-3
Trial details
NCT IDNCT02759887
SponsorSt. Joseph's Hospital and Medical Center, Phoenix