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Vitamin

1 for Down Syndrome

Phase 3
Waitlist Available
Led By Arthur J Dalton, PhD
Research Sponsored by New York State Institute for Basic Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, every 6 months for 36 months
Awards & highlights

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.

Eligible Conditions
  • Down Syndrome
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, and every 6 months for 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, and every 6 months for 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements
Secondary outcome measures
Fuld Object Memory Test (Modified), New Dot Test, Orientation Test, Vocabulary Test, Behavior & Function Down Syndrome Rating Scale, Clinical Global Impression of Change (CGI-C)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment2 Interventions
vitamin E plus multivitamin
Group II: 2Placebo Group2 Interventions
placebo with multivitamin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
multivitamin
1999
Completed Phase 3
~430
Vitamin E
FDA approved

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,583 Total Patients Enrolled
1 Trials studying Down Syndrome
349 Patients Enrolled for Down Syndrome
New York State Institute for Basic ResearchLead Sponsor
6 Previous Clinical Trials
614 Total Patients Enrolled
1 Trials studying Down Syndrome
349 Patients Enrolled for Down Syndrome
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,713 Total Patients Enrolled
9 Trials studying Down Syndrome
997 Patients Enrolled for Down Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vitamin E in Aging Persons With Down Syndrome
Arthur Dalton 2002. "Vitamin E in Aging Persons With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00056329.
All > Aging > Down Syndrome
~15 spots leftby Apr 2025
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