VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring homocysteine
Eligibility 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
Sites / Locations
- University of Alabama
- Mayo Clinic, Scottsdale
- Sun Health Research Institute
- University of Arizona, Arizona Health Sciences Center
- University of California, Irvine, Institute for Brain Aging and Dementia
- University of California, San Diego
- University of Southern California
- University of California, Los Angeles
- Stanford University
- University of California, Davis
- Yale University
- Georgetown University
- Howard University
- Mayo Clinic
- University of South Florida
- Emory University
- Northwestern University
- Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center
- Southern Illinois University
- Indiana University
- Brigham and Women's Hospital
- Boston University School of Medicine
- University of Michigan
- University of Nevada School of Medicine, Center for Cognitive Aging
- ClinSearch
- New York University Medical Center
- Mt. Sinai School of Medicine
- Columbia University
- University of Rochester Medical Center, Alzheimer's Disease Center
- University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
- Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center
- University of Pennsylvania
- University of Pittsburgh
- Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic
- Medical University of South Carolina
- University of Texas, Southwestern Medical Center
- Baylor College of Medicine
- University of Washington