HIGH DOSE SUPPLEMENTS TO REDUCE HOMOCYSTEINE IN ALZHEIMER'S DISEASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There is strong evidence that relatively high homocysteine levels are associated with Alzheimer's disease, and may contribute to disease pathophysiology by causing vascular and neuronal damage. Homocysteine levels can be reduced by administration of high dose supplements of folic acid, vitamins B6 and B12. This is a parallel design, randomized controlled study with two groups of unequal size: 60% of participants will receive daily high dose supplements (folic acid 5mg, vitamin B6 25mg and B12 1 mg), and 40% will receive identical placebo. 400 subjects with a diagnosis of AD will be enrolled in the trial with approximately 10 subjects recruited at this site. Participants will be treated with this regime for a total of 18 months with cognitive, behavioral and clinical assessments done every three months. Participants must be accompanied by a "study partner" to the visits. The primary outcome measure will be the longitudinal decline in the ADAScog score. Secondary outcome measures include the CDR sum of boxes, ADCS Activities of Daily Living, Pharmacoeconomic scales, the Quality of Life-AD and the Neuropsychiatry Inventory.