VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)
NCT ID: NCT00056225
Last Updated: 2009-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2003-01-31
2007-06-30
Brief Summary
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Detailed Description
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This will be a parallel design study, including two groups of unequal size: 60% of subjects will receive daily high-dose supplements (folate 5mg, vitamin B6 25mg, vitamin B12 1 mg), and 40% will receive an identical looking placebo. The duration of treatment will be 18 months, and participants will make eight visits to the assigned study site for safety and efficacy assessments of the medications. The primary outcome measure will be the longitudinal decline in the ADAScog, a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis (Rosen et al 1984). To power the trial to detect a 25% reduction in rate of ADAScog decline (80% power, alpha=0.05, drop-out estimate 20%, drop-in estimate 10%), it will enroll a total of 400 participants. Persons of minority racial groups are also being recruited, although all participants must be able to speak either English or Spanish.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Folate
Vitamin B6
Vitamin B12
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental Status Examination (MMSE) score between 14 and 26, inclusive
* Stable medical condition for 3 months
* Stable medications for 4 weeks prior to the screening visit
* Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests
* Supervision available for administration of study medications
* Study partner to accompany subject to all scheduled visits
* Fluent in English or Spanish
* Modified Hachinski equal to or less than 4 CT or magnetic resonance imaging (MRI) since onset of memory impairment demonstrating absence of clinically significant focal lesion
* Able to complete baseline assessments
* 6 years of education or work history sufficient to exclude mental retardation
* Able to ingest oral medication
Exclusion Criteria
* Renal insufficiency (serum creatinine \>=2.0)
* Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
* Use of another investigational agent within 2 months
* History of clinically significant stroke
* Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury, or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol
55 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
National Institute on Aging (NIA)
NIH
Principal Investigators
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Paul Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University, Department of Neurology
Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic, Scottsdale
Scottsdale, Arizona, United States
Sun Health Research Institute
Sun City, Arizona, United States
University of Arizona, Arizona Health Sciences Center
Tucson, Arizona, United States
University of California, Irvine, Institute for Brain Aging and Dementia
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, Davis
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Nevada School of Medicine, Center for Cognitive Aging
Las Vegas, Nevada, United States
ClinSearch
Kenilworth, New Jersey, United States
New York University Medical Center
New York, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center, Alzheimer's Disease Center
Rochester, New York, United States
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, United States
Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic
Pawtucket, Rhode Island, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Seshadri S, Beiser A, Selhub J, Jacques PF, Rosenberg IH, D'Agostino RB, Wilson PW, Wolf PA. Plasma homocysteine as a risk factor for dementia and Alzheimer's disease. N Engl J Med. 2002 Feb 14;346(7):476-83. doi: 10.1056/NEJMoa011613.
Aisen PS, Egelko S, Andrews H, Diaz-Arrastia R, Weiner M, DeCarli C, Jagust W, Miller JW, Green R, Bell K, Sano M. A pilot study of vitamins to lower plasma homocysteine levels in Alzheimer disease. Am J Geriatr Psychiatry. 2003 Mar-Apr;11(2):246-9.
Kruman II, Kumaravel TS, Lohani A, Pedersen WA, Cutler RG, Kruman Y, Haughey N, Lee J, Evans M, Mattson MP. Folic acid deficiency and homocysteine impair DNA repair in hippocampal neurons and sensitize them to amyloid toxicity in experimental models of Alzheimer's disease. J Neurosci. 2002 Mar 1;22(5):1752-62. doi: 10.1523/JNEUROSCI.22-05-01752.2002.
Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, van Dyck CH, Weiner MF, Bottiglieri T, Jin S, Stokes KT, Thomas RG, Thal LJ; Alzheimer Disease Cooperative Study. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA. 2008 Oct 15;300(15):1774-83. doi: 10.1001/jama.300.15.1774.
Other Identifiers
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IA0041
Identifier Type: -
Identifier Source: org_study_id
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