Study Results
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Basic Information
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UNKNOWN
PHASE3
350 participants
INTERVENTIONAL
2002-04-30
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
vitamin E plus multivitamin
Vitamin E
1,000 international units twice daily for three years
multivitamin
once daily for three years
2
placebo with multivitamin
multivitamin
once daily for three years
Placebo
Placebo twice daily for three years
Interventions
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Vitamin E
1,000 international units twice daily for three years
multivitamin
once daily for three years
Placebo
Placebo twice daily for three years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically stable.
* Medications stable over 3 months.
* Appropriately signed and witnessed consent form.
* Involvement/cooperation of informant/caregiver.
Exclusion Criteria
* 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.
50 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
New York State Institute for Basic Research
OTHER_GOV
Responsible Party
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Arthur Dalton
Deputy Director
Principal Investigators
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Arthur J Dalton, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Institute for Basic Research in Developmental Disabilities
Paul S Aisen, MD
Role: STUDY_DIRECTOR
Georgetown University
Mary C Sano, PhD
Role: STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai
Locations
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University of Connecticut Health Center
Farmington, Connecticut, United States
Roskamp Institute Memory Clinic
Tampa, Florida, United States
Institute for the Study of Disadvantage and Disability
Atlanta, Georgia, United States
May South, Inc.
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Third Age, Inc.
Lexington, Kentucky, United States
McLean Hospital
Belmont, Massachusetts, United States
Clinical Research Center of New Jersey
Voorhees Township, New Jersey, United States
University at Albany, SUNY
Albany, New York, United States
Nathan Kline Institute
Orangeburg, New York, United States
George Jervis Clinic
Staten Island, New York, United States
Westchester Institute for Human Development
Valhalla, New York, United States
University Memory and Aging Center, Case Western Reserve University
Cleveland, Ohio, United States
Centre for Developmental Disabilities Studies
Ryde, New South Wales, Australia
Down Syndrome Research Foundation
Port Coquitlam, British Columbia, Canada
Surrey Place Centre
Toronto, Ontario, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
University of Cambridge
Cambridge, England, United Kingdom
Greenfields Monyhull Hospital
Kings Norton, Birmingham, England, United Kingdom
Kings College: London
London, England, United Kingdom
Mercer Institute for Research on Ageing, St. James Hospital
Dublin, Ireland, United Kingdom
Countries
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References
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Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22. doi: 10.1056/NEJM199704243361704.
Aisen PS, Davis KL. The search for disease-modifying treatment for Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 6):S35-41. doi: 10.1212/wnl.48.5_suppl_6.35s.
Aylward EH, Burt DB, Thorpe LU, Lai F, Dalton A. Diagnosis of dementia in individuals with intellectual disability. J Intellect Disabil Res. 1997 Apr;41 ( Pt 2):152-64. doi: 10.1111/j.1365-2788.1997.tb00692.x.
Dalton, AJ, Mehta, PD, Fedor, BL, Patti, PJ: Cognitive changes in memory precede those in praxis in aging persons with Down syndrome. Journal of Intellectual and Developmental Disability 24(2):169-187,1999.
Sano M, Aisen PS, Dalton AJ, Andrews HF, Tsai W-Y, and the International Down Syndrome Alzheimer Disease Consortium. Assessment of aging individuals with Down syndrome in clinical trials: results of baseline measures. Journal of Policy and Practice in Intellectual Disabilities. 2005 2(2):126-138.
Other Identifiers
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NIA Grant AG16381
Identifier Type: -
Identifier Source: secondary_id
IA0039
Identifier Type: -
Identifier Source: org_study_id
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