Vitamin E in Aging Persons With Down Syndrome
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|ClinicalTrials.gov Identifier: NCT00056329|
Recruitment Status : Unknown
Verified May 2012 by Arthur Dalton, New York State Institute for Basic Research.
Recruitment status was: Active, not recruiting
First Posted : March 12, 2003
Last Update Posted : May 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Alzheimer Disease||Drug: Vitamin E Drug: multivitamin Drug: Placebo||Phase 3|
The growing success of therapeutic interventions (including the antioxidant Vitamin E) for Alzheimer's disease in the general population requires a solution to the methodological problems so that therapeutic trials can be conducted in the aging population with Down syndrome which will ultimately improve their quality of life as well as that of their families and caregivers. The experience gained in this trial will be useful to the design of appropriate cognitive measures of Alzheimer's disease in persons with Down syndrome in subsequent trials.
The goal of this international three-year study is to determine whether the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, will slow the rate of cognitive/functional decline in persons age 50 or older with Down syndrome. Persons with Down syndrome functioning at all levels of intellectual disability will be eligible. Men and women of approximately equal numbers and people from minorities and ethnic groups other than Caucasian will be included. A total of 350 individuals with Down syndrome, 50 years of age and older, have been recruited at approximately 21 trial sites. The study is a randomized, double-blind, placebo-controlled, parallel group design with stratification by geographic site and presence of Alzheimer disease according to DSM-IV (American Psychiatric Association) criteria for diagnosing this disease.
Apolipoprotein E (Apo E) genotype will be determined at the screening visit to allow secondary analyses of the impact of Apo E genotype (that may influence Alzheimer's disease risk) on outcome measures and the response to treatment. DNA specimens will also be stored for possible future genetic analyses, with trial sites allowing for non-participation in this procedure. Visits will occur at baseline and then at 6 monthly intervals, with each visit including interval medical history, current and interval medications, side effects checklist, adverse events, pill count, institutionalization status, cognitive, functional, and behavioral measures, and DSM-IV diagnostic assessment for Alzheimer's disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter Vitamin E Trial in Aging Persons With Down Syndrome|
|Study Start Date :||April 2002|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
vitamin E plus multivitamin
Drug: Vitamin E
1,000 international units twice daily for three years
Other Name: tocopherol
once daily for three years
Placebo Comparator: 2
placebo with multivitamin
once daily for three years
Placebo twice daily for three years
- Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements [ Time Frame: Screening, Baseline, every 6 months for 36 months ]
- 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) [ Time Frame: Screening, Baseline, and every 6 months for 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056329
|Principal Investigator:||Arthur J Dalton, PhD||New York State Institute for Basic Research in Developmental Disabilities|
|Study Director:||Paul S Aisen, MD||Georgetown University|
|Study Director:||Mary C Sano, PhD||Icahn School of Medicine at Mount Sinai|