Not Signed In -
Vitamin B6 (Pyridoxine) |
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Clinical Trial: VITAL - VITamins to slow ALzheimer's disease (Homocysteine Study)
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: Folate Drug: Vitamin B6 Drug: Vitamin B12 | Phase III |
MedlinePlus related topics: Alzheimer's Caregivers; Alzheimer's Disease
Genetics Home Reference related topics: Alzheimer disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to slow Alzheimer's - VITAL)
Expected Total Enrollment: 400
Study start: January 2003; Expected completion: February 2006
Blood levels of homocysteine are elevated in Alzheimer’s disease (AD), and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Homocysteine levels can be reduced by administration of high dose supplements of folate (folic acid) and vitamins B6 and B12. The proposed study is for a multicenter, randomized, controlled clinical trial to determine whether reduction of homocysteine levels with high-dose folate/B6/B12 supplementation will slow the rate of cognitive decline in subjects with AD.
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.
Eligibility
Ages Eligible for Study: 55 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 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
- 6 years of education or work history sufficient to exclude mental retardation
- Able to ingest oral medication
Exclusion Criteria:
- B12 or folate deficiency
- 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
Location and Contact Information
Alabama
University of Alabama, Birmingham, Alabama, 35294, United States; Recruiting
Arizona
University of Arizona, Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Geoff Ahern, MD, PhD, Principal Investigator
Mayo Clinic, Scottsdale, Scottsdale, Arizona, 85259, United States; Recruiting
Richard Caselli, MD, Principal Investigator
Sun Health Research Institute, Sun City, Arizona, 85351, United States; Recruiting
California
Stanford University, Palo Alto, California, 94304, United States; Recruiting
University of California, Davis, Sacramento, California, 95817, United States; Recruiting
Charles DeCarli, MD, Principal Investigator
University of California, Irvine, Institute for Brain Aging and Dementia, Irvine, California, 92697, United States; Recruiting
Ruth Mulnard, RN, DNSc, Principal Investigator
University of California, Los Angeles, Los Angeles, California, 90095, United States; Recruiting
John M. Ringman, MD, Principal Investigator
University of California, San Diego, La Jolla, California, 92093-0624, United States; Recruiting
University of Southern California, Los Angeles, California, 90033, United States; Recruiting
Lon Schneider, MD, Principal Investigator
Connecticut
Yale University, New Haven, Connecticut, 06510, United States; Recruiting
District of Columbia
Georgetown University, Washington, DC, District of Columbia, 20057, United States; Recruiting
Howard University, Washington, DC, District of Columbia, 20060, United States; Recruiting
Thomas Obisesan, MD, Principal Investigator
Florida
University of South Florida, Tampa, Florida, 33617, United States; Recruiting
Eric A. Pfeiffer, MD, Principal Investigator
Mayo Clinic, Jacksonville, Florida, 32224, United States; Recruiting
Neill Graff-Radford, MD, Principal Investigator
Georgia
Emory University, Atlanta, Georgia, 30329, United States; Recruiting
Larry Tune, MD, Principal Investigator
Illinois
Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Marsel Mesulam, MD, Principal Investigator
Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center, Chicago, Illinois, 60612, United States; Recruiting
Neelum T. Aggarwal, MD, Principal Investigator
Southern Illinois University, Springfield, Illinois, 62794-9643, United States; Recruiting
Sandra Vicari, MD, Principal Investigator
Indiana
Indiana University, Indianapolis, Indiana, 46202, United States; Recruiting
Martin Farlow, MD, Principal Investigator
Massachusetts
Boston University School of Medicine, Boston, Massachusetts, 02118, United States; Recruiting
Robert Green, MD, MPH, Principal Investigator
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Reisa Sperling, MD, Principal Investigator
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States; Recruiting
Nevada
University of Nevada School of Medicine, Center for Cognitive Aging, Las Vegas, Nevada, 89102, United States; Recruiting
Charles Bernick, MD, Principal Investigator
New Jersey
ClinSearch, Kenilworth, New Jersey, 07033, United States; Recruiting
New York
Columbia University, New York, New York, 10032, United States; Recruiting
Karen L. Bell, MD, Principal Investigator
Mt. Sinai School of Medicine, New York, New York, 10029, United States; Recruiting
Hillel Grossman, Principal Investigator
New York University Medical Center, New York, New York, 10016, United States; Recruiting
University of Rochester Medical Center, Alzheimer's Disease Center, Rochester, New York, 14620, United States; Recruiting
Ohio
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland, Cleveland, Ohio, 44120, United States; Recruiting
Elaine Ziol 800-252-5048 exz5@po.cwru.edu
Paula Ogrocki, PhD, Principal Investigator
Oregon
Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center, Portland, Oregon, 97201, United States; Recruiting
Joseph Quinn, MD, Principal Investigator
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Christopher Clark, MD, Principal Investigator
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Steven T. DeKosky, MD, Principal Investigator
Rhode Island
Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic, Pawtucket, Rhode Island, 02860, United States; Recruiting
Brian R. Ott, Principal Investigator
South Carolina
Medical University of South Carolina, North Charleston, South Carolina, 29406, United States; Recruiting
Jacobo E. Mintzer, MD, Principal Investigator
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Rachelle Doody, MD, PhD, Principal Investigator
University of Texas, Southwestern Medical Center, Dallas, Texas, 75390, United States; Recruiting
Myron F. Weiner, MD, Principal Investigator
Washington
University of Washington, Seattle, Washington, 98108, United States; Recruiting
Elaine Peskind, MD, Principal Investigator
Paul Aisen, MD, Principal Investigator, Georgetown University, Department of Neurology
More Information
Publications
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.
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.
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: March 7, 2003
ClinicalTrials.gov Identifier: NCT00056225
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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