Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Institute for Basic Research
• Collaborators: Bronx Veterans Medical Research Foundation, Inc; Columbia University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Complementary and Integrative Health (NCCIH); National Institute on Aging (NIA); New York State Psychiatric Institute; University of California, San Diego
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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