Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
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ClinicalTrials.gov Identifier: NCT01594346 |
Recruitment Status
:
Completed
First Posted
: May 9, 2012
Last Update Posted
: May 9, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Down Syndrome | Drug: Alpha-Tocopherol Drug: Sugar Pill | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 349 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sugar Pill | Drug: Sugar Pill |
Active Comparator: Alpha-Tocopherol |
Drug: Alpha-Tocopherol
1,000 International Units, two times a day for 36 months
Other Name: Vitamin E
|
- The Brief Praxis Test [ Time Frame: 36 months ]
- The Fuld Object Memory Test [ Time Frame: 36 Months ]
- New Dot Test [ Time Frame: 36 Months ]
- Orientation Test [ Time Frame: 36 Months ]
- Vocabulary Test [ Time Frame: 36 Months ]
- Behavior and Function [ Time Frame: 36 Months ]
- Clinical Global Impression [ Time Frame: 36 Months ]
- Incident Dementia [ Time Frame: 36 Months ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594346
Study Director: | Paul S. Aisen, M.D. | University of California, San Diego | |
Study Director: | Mary C. Sano, Ph.D. | Bronx Veterans Medical Research Foundation | |
Study Director: | Howard F. Andrews, Ph.D. | New York Psychiatric Institute | |
Study Director: | Wei-Yann Tsai, Ph.D. | Columbia University |
Responsible Party: | Arthur Dalton, Deputy Director, New York State Institute for Basic Research |
ClinicalTrials.gov Identifier: | NCT01594346 History of Changes |
Other Study ID Numbers: |
R01AG016381 ( U.S. NIH Grant/Contract ) |
First Posted: | May 9, 2012 Key Record Dates |
Last Update Posted: | May 9, 2012 |
Last Verified: | May 2012 |
Keywords provided by Arthur Dalton, New York State Institute for Basic Research:
Vitamin E alpha-tocopherol cognitive decline |
Down syndrome Aging Dementia |
Additional relevant MeSH terms:
Syndrome Alzheimer Disease Down Syndrome Disease Pathologic Processes Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Vitamins Vitamin E Tocopherols Tocotrienols alpha-Tocopherol Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action |