NCT01594346

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

9.6 years

First QC Date

May 2, 2012

Last Update Submit

May 8, 2012

Conditions

Alzheimer's DiseaseDown Syndrome

Keywords

Vitamin Ealpha-tocopherolcognitive declineDown syndromeAgingDementia

Outcome Measures

Primary Outcomes (1)

  • The Brief Praxis Test

    36 months

Secondary Outcomes (7)

  • The Fuld Object Memory Test

    36 Months

  • New Dot Test

    36 Months

  • Orientation Test

    36 Months

  • Vocabulary Test

    36 Months

  • Behavior and Function

    36 Months

  • +2 more secondary outcomes

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR
Drug: Sugar Pill

Alpha-Tocopherol

ACTIVE COMPARATOR
Drug: Alpha-Tocopherol

Interventions

Alpha-TocopherolDRUG

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

Also known as: Vitamin E
Alpha-Tocopherol
Sugar PillDRUG
Sugar Pill

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDown SyndromeCognitive DysfunctionDementia

Interventions

alpha-TocopherolVitamin ESugars

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornCognition Disorders

Intervention Hierarchy (Ancestors)

TocopherolsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarbohydrates

Study Officials

  • Paul S. Aisen, M.D.

    University of California, San Diego

    STUDY DIRECTOR

  • Mary C. Sano, Ph.D.

    Bronx Veterans Medical Research Foundation

    STUDY DIRECTOR

  • Howard F. Andrews, Ph.D.

    New York Psychiatric Institute

    STUDY DIRECTOR

  • Wei-Yann Tsai, Ph.D.

    Columbia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 9, 2012

Study Start

September 1, 2000

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 9, 2012

Record last verified: 2012-05