In response to the RFA related to cholesterol lowering in the elderly, Bowman Gray proposes to aid in protocol development and testing at a Clinical Center based in Forsyth County, NC. A strong research team is drawn together to respond including Drs. John Crouse, P.I., William Hazzard, Co P.I., and Curt Furberg, Chair of the Advisory Committee, Grethe Tell, Project Coordinator, and Terry Dolecek, Nutrition Coordinator, and a strong research environment is present at Bowman Gray in Cardiovascular Epidemiology/Clinical Trials and Gerontology. We have recently successfully competed for one of the Clinical Centers for the Cardiovascular Health Study (CHS) and all the resources of that study will be available for this trial. The institution is laying foundations to become one of the preeminent centers in the nation in gerontology. During protocol development we will provide expertise in lipids and lipid metabolism, in epidemiology/clinical trials, nutrition, and gerontology. The community is ideally suited for the study as regards recruitment because of the tight network of elderly individuals and the groundwork laid by CHS. Clinic facilities (unused by CHS and therefore available for the pilot in 1991) are excellent. Unique aspects of the proposal include (1.) A formal comparison of various approaches to recruitment; (2.) a simple, effective nutritional intervention; (3.) use of elderly volunteers to aid in clinic operations; (4.) randomization of subjects 60:40::drug:placebo to provide more experience with active drug without sacrificing statistical power; and (5.) a coordinated drug-dosage scheme to titrate drug dose to achieve target LDL concentrations. With the proposed clinic design the study can be implemented at a reasonable cost.
