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Home > "V" Clinical Trials Conditions > Vitamin E in Aging Persons With Down Syndrome  Vitamin E in Aging Persons With Down Syndrome
Vitamin E in Aging Persons With Down Syndrome
For Condition: Alzheimer Disease,Down Syndrome
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) , National Institute of Child Health and Human Development (NICHD),National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: 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.
Details: 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 400 individuals with Down syndrome, 50 years of age and older, will be recruited at approximately 27 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. The primary outcome measure is a brief test of praxis, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements in persons with Down syndrome with mild to profound levels of mental retardation. A vitamin E regimen (1,000 international units twice daily, plus a multivitamin) or a placebo will be compared to a multivitamin alone in a two-arm parallel group design. Apoliproprotein 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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. Exclusion Criteria: - 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.
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
MarySano, Study Director, Mount Sinai Medical Center
Westchester Institute for Human Development *Recruiting*
Valhalla, New York, 10595
United States
Recruiting MaryEllen Ryan 914-493-8174
Kings College: London *Recruiting*
London, England, SE5 8AF
United Kingdom
Recruiting Felix Beacher 44 20 78480867
Nathan Kline Institute *Recruiting*
Orangeburg, New York, 10962
United States
Recruiting Raymundo Hernando 845-398-5578
Roskamp Institute Memory Clinic *Recruiting*
Tampa, Florida, 33617
United States
Recruiting Timothy Crowell 813-979-2008
Greenfields Monyhull Hospital *Recruiting*
Kings Norton, Birmingham, England, B30 3QQ
United Kingdom
Recruiting Claire Adams 44 121 2558013
Third Age, Inc. *Recruiting*
Lexington, Kentucky, 40517
United States
Recruiting James Stone 859-272-6001
University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Cindy Gruman 860-545-7012
University of Cambridge *Recruiting*
Cambridge, England, CB2 2AH
United Kingdom
Recruiting Sarah Ball 44 122 374 6118
Saskatoon City Hospital *Recruiting*
Saskatoon, Saskatchewan, S7K 0M7
Canada
Recruiting Sarah Bocking 306-655-7873
George Jervis Clinic *Recruiting*
Staten Island, New York, 10314
United States
Recruiting Paul Patti 718-494-5315
Mercer Institute for Research on Ageing, St. James Hospital *Recruiting*
Dublin, Ireland, 8
United Kingdom
Recruiting Margaret Mann 011-353-1-4162640
University at Albany, SUNY *Recruiting*
Albany, New York, 12222
United States
Recruiting Philip McCallion 518-442-5347
University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60608
United States
Recruiting Kelly Hsieh 312-413-1530
Down Syndrome Research Foundation *Recruiting*
Port Coquitlam, British Columbia, V3C 2B2
Canada
Recruiting Anne Eichmann 604-444-3773
Surrey Place Centre *Recruiting*
Toronto, Ontario, M5S 2C2
Canada
Recruiting Maire Percy 416-925-5141
Centre for Developmental Disabilities Studies *Recruiting*
Ryde, New South Wales, 1680
Australia
Recruiting Seeta Durvasula 61 2 88780505
Southern Illinois University School of Medicine *Recruiting*
Springfield, Illinois, 62794-9642
United States
Recruiting Sandra Vicari 217-545-7671
May South, Inc. *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Janice Nodvin 770-956-8511
Denver Down Syndrome Clinic *Recruiting*
Denver, Colorado, 80206
United States
Recruiting Steffi Gratigny 303-797-1699
University of California, Irvine *Recruiting*
Irvine, California, 92697
United States
Recruiting Eric Doran 714-456-8443
Developmental Disabilities Health Alliance *Recruiting*
Bloomfield, New Jersey, 07003
United States
Recruiting Kevin Walsh 856-782-8989
Bancroft Neurohealth *Recruiting*
Cherry Hill, New Jersey, 08034
United States
Recruiting Marie DeGaetano 856-616-6445
Kennedy Krieger Institute *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting Heather Kammann 443-923-9132
McLean Hospital *Recruiting*
Belmont, Massachusetts, 02478
United States
Recruiting Florence Lai 617-855-3266
Additional Information:
Study ID Numbers: IA0039; NIA Grant AG16381
Study Start Date: April 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056329
Other Alzheimer Disease Studies:
1. Vitamin E in Aging Persons With Down Syndrome
2. Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters
3. Reproduction and Survival After Cardiac Defect Repair
Related Studies:
Other Alzheimer Disease Clinical Trials
Other New Jersey Clinical Trials
Other Bloomfield Clinical Trials
Vitamin E in Aging Persons With Down Syndrome
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