Vitamin E in Aging Persons With Down Syndrome
- Conditions
- Down SyndromeAlzheimer Disease
- Interventions
- Registration Number
- NCT00056329
- Lead Sponsor
- New York State Institute for Basic Research
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Vitamin E vitamin E plus multivitamin 1 multivitamin vitamin E plus multivitamin 2 multivitamin placebo with multivitamin 2 Placebo placebo with multivitamin
- Primary Outcome Measures
Name Time Method Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements Screening, Baseline, every 6 months for 36 months
- Secondary Outcome Measures
Name Time Method 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) Screening, Baseline, and every 6 months for 36 months
Trial Locations
- Locations (22)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
George Jervis Clinic
🇺🇸Staten Island, New York, United States
Third Age, Inc.
🇺🇸Lexington, Kentucky, United States
University at Albany, SUNY
🇺🇸Albany, New York, United States
May South, Inc.
🇺🇸Atlanta, Georgia, United States
Clinical Research Center of New Jersey
🇺🇸Voorhees, New Jersey, United States
Roskamp Institute Memory Clinic
🇺🇸Tampa, Florida, United States
Centre for Developmental Disabilities Studies
🇦🇺Ryde, New South Wales, Australia
Institute for the Study of Disadvantage and Disability
🇺🇸Atlanta, Georgia, United States
University Memory and Aging Center, Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Nathan Kline Institute
🇺🇸Orangeburg, New York, United States
Down Syndrome Research Foundation
🇨🇦Port Coquitlam, British Columbia, Canada
Mercer Institute for Research on Ageing, St. James Hospital
🇬🇧Dublin, Ireland, United Kingdom
Greenfields Monyhull Hospital
🇬🇧Kings Norton, Birmingham, England, United Kingdom
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Westchester Institute for Human Development
🇺🇸Valhalla, New York, United States
Surrey Place Centre
🇨🇦Toronto, Ontario, Canada
Kings College: London
🇬🇧London, England, United Kingdom
Saskatoon City Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
University of Cambridge
🇬🇧Cambridge, England, United Kingdom