ADCS/NIA PROTOCOL ACD-016: HIGH DOSE SUPPLEMENTS AND 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. Blood levels of homocysteine, a sulfur amino acid, have been demonstrated to be elevated in Alzheimer's Disease (AD). Hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Homocysteine levels can be reduced by administration of high dose supplements of folic acid and vitamins B6 and B12. Four drugs have been approved by the FDA for the treatment of AD, all cholinesterase inhibitors. By boosting brain levels of the neurotransmitter acetylcholine, they improve cognitive function. They are considered to be symptomatic treatments; they have not been proven to slow the progression of the disease. This proposal is based on the hypothesis that homocysteine reduction will have a disease-modifying effect in AD. This trial is an eighteen month randomized trial of 400 patients at 40 sites.