HIGH DOSE SUPPLEMENTS TO TREAT 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. This is an NIH-funded multicenter trial to test the primary hypothesis that reduction of homocysteine levels, which are frequently elevated in patients with Alzheimer's disease (AD), will slow the rate of cognitive decline. Secondary endpoints include 1) determining whether such reductions also favorably influence measures of behavior, activities of daily living, global status, quality of life; 2) examining whether ApoE and methylenetetrahydrofolate reductase genotypes influence homocysteine reduction in subjects with AD; and 3) determining the safety and tolerability of long-term treatment of AD subjects with high-dose supplements. Alzheimer's disease is a devastating disease and a major public health problem. Clearly, treatments that may slow disease progression and/or improve quality of life are of great significance. At present, there is no direct evidence causally linking elevations in homocysteine levels with AD progression, only data suggesting that elevated homocysteine levels are a risk factor for AD. This study is designed to test whether a combination of folate, Vitamin B6 and B12 will influence the progression of AD and/or quality of life. It is a Phase III, parallel-design study with two groups of unequal size - 60% receiving supplements and 40% placebo. Treatment duration will be for 18 months. A total of 400 patients will be enrolled overall, with 15 enrolled at this site, of which 10 will use the GCRC. Patients will undergo physical exam and a fairly standard laboratory examination, as well as functional and behavioral testing at each of 8 outpatient visits over the 18-month study period. Genomic DNA will be prepared for polymorphism analysis. Subjects continue to be enrolled on this study. No preliminary findings have been reported yet.