drugset / Trial / NCT01594346
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Phase 3
Completed
349 enrolled
New York State Institute for Basic Research
Bronx Veterans Medical Research Foundation, Inc · collabColumbia University · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Center for Complementary and Integrative Health (NCCIH) · collabNational Institute on Aging (NIA) · collabNew York State Psychiatric Institute · collabUniversity of California, San Diego · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2000-09
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | alpha-tocopherol | Unknown | 1000 iu | — |