Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

This study has been completed.
Sponsor:
Collaborators:
New York State Psychiatric Institute
University of California, San Diego
Columbia University
Bronx Veterans Medical Research Foundation, Inc
Information provided by (Responsible Party):
Arthur Dalton, New York State Institute for Basic Research
ClinicalTrials.gov Identifier:
NCT01594346
First received: May 2, 2012
Last updated: May 8, 2012
Last verified: May 2012

May 2, 2012
May 8, 2012
September 2000
April 2010   (final data collection date for primary outcome measure)
The Brief Praxis Test [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01594346 on ClinicalTrials.gov Archive Site
  • The Fuld Object Memory Test [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • New Dot Test [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Orientation Test [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Vocabulary Test [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Behavior and Function [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Incident Dementia [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Not Provided

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.

Alzheimer disease (AD) continues to be the most serious health problem faced by aging persons with Down syndrome. AD is also a major public health concern in the aging general population. With increasing life expectancy there will be a dramatic increase in the prevalence of AD cases, which will pose a significant increased burden on the health care system and individual providers of care. Persons with Down syndrome are uniquely vulnerable to a form of Alzheimer disease indistinguishable from the sporadic variety that affects aging individuals from the general population. Oxidative damage is a highly plausible mechanism in the pathogenesis of this disease due to the overexpression of superoxide dismutase, associated with a gene located on chromosome 21, which is present in triplicate in the Down syndrome genotype. For the last six years, we have been conducting a clinical trial to determine the safety and efficacy of the anti-oxidant Vitamin E in slowing the cognitive and functional decline associated with the dementia of AD among individuals with DS. The study is a randomized, double-blind trial, stratified in a two-arm parallel design. The subjects are medically stable individuals who are 50 years of age or older at the time of screening. Among those randomized to the treatment arm, vitamin E is taken in the form of 1000 IU capsules for 36 months. Each subject is evaluated every 6 months for 3 years. The primary outcome is is the Brief Praxis Test (BPT), which is well-suited to quantifying cognitive decline in this population. The target enrollment of 350 persons is estimated to be sufficient to provide adequate statistical power to detect a slowing by one-third in the rate of cognitive decline with vitamin E treatment. The Data and Safety Monitoring Board (DSMB) for this trial includes 4 physicians, and a statistician with expertise in clinical trials. Each DSMB member receives a report on each serious adverse event (SAE) on a flow basis, and statistically summaries of unblinded safety data--including deaths, adverse events and vital signs--prior to each meeting of the DSMB. The most recent DSMB meeting took place on February 23,2010. The timeline for study completion is: recruitment of the study sample (N=350) was completed on 12/31/2008; the final 36-month evaluation will take place in 04/2010; statistical analysis and final report of results is expected to be completed by 12/31/2010.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Down Syndrome
  • Drug: Alpha-Tocopherol
    1,000 International Units, two times a day for 36 months
    Other Name: Vitamin E
  • Drug: Sugar Pill
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Sugar Pill
  • Active Comparator: Alpha-Tocopherol
    Intervention: Drug: Alpha-Tocopherol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
349
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01594346
NCT00056329, R01AG016381
Yes
Arthur Dalton, New York State Institute for Basic Research
New York State Institute for Basic Research
  • National Institute on Aging (NIA)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • New York State Psychiatric Institute
  • University of California, San Diego
  • Columbia University
  • Bronx Veterans Medical Research Foundation, Inc
Study Director: 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
New York State Institute for Basic Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP