Alzheimer's Disease Clinical Trial
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.
Status | Completed |
Enrollment | 349 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
New York State Institute for Basic Research | Bronx Veterans Medical Research Foundation, Inc, Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), New York State Psychiatric Institute, University of California, San Diego |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Brief Praxis Test | 36 months | No | |
Secondary | The Fuld Object Memory Test | 36 Months | No | |
Secondary | New Dot Test | 36 Months | No | |
Secondary | Orientation Test | 36 Months | No | |
Secondary | Vocabulary Test | 36 Months | No | |
Secondary | Behavior and Function | 36 Months | No | |
Secondary | Clinical Global Impression | 36 Months | No | |
Secondary | Incident Dementia | 36 Months | No |
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