VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00056225

Run by

National Institute on Aging (NIA)

People needed

340

Starts

2003-01-01

Expected to finish

2007-06-01

Last updated by the study team

2009-06-12

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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
• 6 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)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.