Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

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.

Conditions

• Alzheimer's Disease
• Down Syndrome

Interventions

DRUG

Alpha-Tocopherol

1,000 International Units, two times a day for 36 months

DRUG

Sugar Pill

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• New York State Psychiatric Institute

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Bronx Veterans Medical Research Foundation, Inc

  collaborator OTHER

• New York State Institute for Basic Research

  lead OTHER_GOV

Principal Investigators

• Paul S. Aisen, M.D. · University of California, San Diego

• Mary C. Sano, Ph.D. · Bronx Veterans Medical Research Foundation

• Howard F. Andrews, Ph.D. · New York Psychiatric Institute

• Wei-Yann Tsai, Ph.D. · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-09-30

Primary Completion

2010-04-30

Completion

2010-04-30