Multicenter Vitamin E Trial in Aging Persons With Down Syndrome (NCT01594346) | Clinical Trial Compass
CompletedPhase 3
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
349 participantsStarted 2000-09
Plain-language summary
The purpose of this study is to determine the safety and effectiveness of 2,000 international units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. It is expected that Vitamin E will slow the deterioration in cognitive functions associated with Alzheimer disease.
Who can participate
Age range
50 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:
* presence of clinically determined Down syndrome (karyotypes optional)
* appropriately signed and witnessed consent form
* age of 50 years or older at the start of the protocol
* medically stable
* medications stable more than 1 month
* involvement/cooperation of informant/caregiver
Exclusion Criteria:
* medical/neurological condition (other than Alzheimer disease) associated with dementia
* inability to adequately perform the Brief Praxis Test, as demonstrated by a score \<20
* in the presence of dementia, modified Hachinski score \> 4 at Screening Visit
* major depression within 3 months
* history of coagulopathy (inherited or acquired)
* current use of anticoagulants
* use of experimental medications within 2 months
* regular use of vitamin E greater than 50 units per day during the previous 6 months
* allergy to vitamin E
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
The Brief Praxis Test
Timeframe: 36 months
Trial details
NCT IDNCT01594346
SponsorNew York State Institute for Basic Research