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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS)
• Treatments: Hydroxocobalamin; Pyridoxal; Pyridoxine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

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