Vitamin E in Aging Persons With Down Syndrome
This trial is active, not recruiting.
|Conditions||down syndrome, alzheimer disease|
|Treatments||vitamin e, multivitamin, placebo|
|Sponsor||New York State Institute for Basic Research|
|Collaborator||National Institute on Aging (NIA)|
|Start date||April 2002|
|End date||May 2012|
|Trial size||350 participants|
|Trial identifier||NCT00056329, IA0039, NIA Grant AG16381, R01AG016381|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Farmington, CT||University of Connecticut Health Center||no longer recruiting|
|Tampa, FL||Roskamp Institute Memory Clinic||no longer recruiting|
|Atlanta, GA||May South, Inc.||no longer recruiting|
|Atlanta, GA||Institute for the Study of Disadvantage and Disability||no longer recruiting|
|Chicago, IL||University of Illinois at Chicago||no longer recruiting|
|Springfield, IL||Southern Illinois University School of Medicine||no longer recruiting|
|Lexington, KY||Third Age, Inc.||no longer recruiting|
|Belmont, MA||McLean Hospital||no longer recruiting|
|Voorhees, NJ||Clinical Research Center of New Jersey||no longer recruiting|
|Albany, NY||University at Albany, SUNY||no longer recruiting|
|Orangeburg, NY||Nathan Kline Institute||no longer recruiting|
|Staten Island, NY||George Jervis Clinic||no longer recruiting|
|Valhalla, NY||Westchester Institute for Human Development||no longer recruiting|
|Cleveland, OH||University Memory and Aging Center, Case Western Reserve University||no longer recruiting|
|Ryde, Australia||Centre for Developmental Disabilities Studies||no longer recruiting|
|Port Coquitlam, Canada||Down Syndrome Research Foundation||no longer recruiting|
|Toronto, Canada||Surrey Place Centre||no longer recruiting|
|Saskatoon, Canada||Saskatoon City Hospital||no longer recruiting|
|Cambridge, United Kingdom||University of Cambridge||no longer recruiting|
|Kings Norton, Birmingham, United Kingdom||Greenfields Monyhull Hospital||no longer recruiting|
|London, United Kingdom||Kings College: London||no longer recruiting|
|Dublin, United Kingdom||Mercer Institute for Research on Ageing, St. James Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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
Male or female participants at least 50 years old.
- Presence of clinically determined Down syndrome (karyotypes optional).
- Medically stable.
- Medications stable over 3 months.
- Appropriately signed and witnessed consent form.
- Involvement/cooperation of informant/caregiver.
- Medical/neurological condition (other than Alzheimer's disease) associated with dementia.
- Brief Praxis Test score <20.
- Modified Hachinski score >4.
- Major depression within 3 months.
- History of any disorder of blood coagulation (inherited or acquired).
- Current use of anti-coagulants.
- Use of experimental medications within 3 months.
- Regular use of vitamin E greater than 50 units per day during the previous 6 months.
|Official title||Multicenter Vitamin E Trial in Aging Persons With Down Syndrome|
|Principal investigator||Arthur J Dalton, PhD|
|Description||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.|
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