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| Descriptive Information Fields | |||||||||||||
| Brief Title † | Vitamin E in Aging Persons With Down Syndrome | ||||||||||||
| Official Title † | Multicenter Vitamin E Trial in Aging Persons With Down Syndrome | ||||||||||||
| Brief 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. |
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| Detailed 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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| Study Phase | Phase III | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||
| Primary Outcome Measure † | 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 ] [ Designated as safety issue: No ] | ||||||||||||
| Secondary Outcome Measure † | 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 ] [ Designated as safety issue: No ] | ||||||||||||
| Condition † | Down Syndrome Alzheimer Disease |
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| Intervention † | Drug: Vitamin E Drug: multivitamin Drug: Placebo |
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| MEDLINE PMIDs | 9110909, 9153159, 9161927 | ||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Active, not recruiting | ||||||||||||
| Enrollment † | 350 | ||||||||||||
| Start Date † | April 2002 | ||||||||||||
| Completion Date | August 2010 | ||||||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 50 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | United States, Australia, Canada, United Kingdom | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00056329 | ||||||||||||
| Organization ID | IA0039 | ||||||||||||
| Secondary IDs †† | NIA Grant AG16381 | ||||||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||||||
| Collaborators †† | National Institute of Child Health and Human Development (NICHD) National Center for Complementary and Alternative Medicine (NCCAM) |
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| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||||||
| Verification Date | February 2008 | ||||||||||||
| First Received Date † | March 10, 2003 | ||||||||||||
| Last Updated Date | February 20, 2008 | ||||||||||||