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Vitamin E in Aging Persons With Down Syndrome

NCT00056329 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2012-05-04

No results posted yet for this study

Summary

The goal of this study is to determine the safety and efficacy of the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, in slowing the rate of cognitive/functional decline in older persons with Down syndrome.

Conditions

  • Down Syndrome
  • Alzheimer Disease

Interventions

DRUG

Vitamin E

1,000 international units twice daily for three years

DRUG

multivitamin

once daily for three years

DRUG

Placebo

Placebo twice daily for three years

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 Institute for Basic Research

    lead OTHER_GOV

Principal Investigators

  • Arthur J Dalton, PhD · New York State Institute for Basic Research in Developmental Disabilities

  • Paul S Aisen, MD · Georgetown University

  • Mary C Sano, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00056329 on ClinicalTrials.gov