VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)
High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to Slow Alzheimer's - VITAL)
1 other identifier
interventional
340
1 country
38
Brief Summary
The purpose of this study is to determine whether reduction of homocysteine levels with high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2003
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 7, 2003
CompletedFirst Posted
Study publicly available on registry
March 10, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJune 12, 2009
June 1, 2009
4.4 years
March 7, 2003
June 10, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- National Institute of Neurological Disorders and Stroke (NINDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) criteria for probable Alzheimer's disease.
- 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
- years of education or work history sufficient to exclude mental retardation
- Able to ingest oral medication
You may not qualify if:
- B12 or folate deficiency
- Renal insufficiency (serum creatinine \>=2.0)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
University of Alabama
Birmingham, Alabama, 35294, United States
Mayo Clinic, Scottsdale
Scottsdale, Arizona, 85259, United States
Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of Arizona, Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University of California, Irvine, Institute for Brain Aging and Dementia
Irvine, California, 92697, United States
University of California, San Diego
La Jolla, California, 92093-0624, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94304, United States
University of California, Davis
Sacramento, California, 95817, United States
Yale University
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University of South Florida
Tampa, Florida, 33617, United States
Emory University
Atlanta, Georgia, 30329, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center
Chicago, Illinois, 60612, United States
Southern Illinois University
Springfield, Illinois, 62794-9643, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Nevada School of Medicine, Center for Cognitive Aging
Las Vegas, Nevada, 89102, United States
ClinSearch
Kenilworth, New Jersey, 07033, United States
New York University Medical Center
New York, New York, 10016, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
University of Rochester Medical Center, Alzheimer's Disease Center
Rochester, New York, 14620, United States
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
Cleveland, Ohio, 44120, United States
Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center
Portland, Oregon, 97201, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic
Pawtucket, Rhode Island, 02860, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98108, United States
Related Publications (4)
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.
PMID: 11844848BACKGROUNDAisen 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.
PMID: 12611755BACKGROUNDKruman 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.
PMID: 11880504BACKGROUNDAisen 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.
PMID: 18854539RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Aisen, MD
Georgetown University, Department of Neurology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 7, 2003
First Posted
March 10, 2003
Study Start
January 1, 2003
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
June 12, 2009
Record last verified: 2009-06