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. Three hundred, non-demented women, 65 years of age or older, with a family history of Alzheimer's Disease (AD) will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial of estrogen alone or combined estrogen and progesterone therapy. Women will be recruited over an 18-month period, using 4 distinct methods: 1) Healthy non-demented women relatives of patients with AD, 2) Women with a family history of AD contacted through community service providers surrounding the medical center, 3) Women with a family history of AD identified through advertisement using local media (newspapers, television and radio), and 4) Women with a family history of AD identified from a regional sample of female Medicare recipients provided by the Health Care Finance Administration (HCFA). At study end, family history of AD will be confirmed and each participant will have a physical, neuropsychological, and functional assessment to insure the absence of dementia and other degenerative neurological disease or potentially fatal disorder. Women with a history of breast, uterine or ovarian cancer and those with a history of breast cancer in a first-stage relative will be excluded. Randomizationto estrogen, estrogen with progesterone, or identical placebo among eligible women will be stratified by site and hysterectomy status (women who have undergone hysterectomy will be randomized to unopposed estrogen or placebo; women who have not undergone hysterectomy will be randomized to oposed estrogen or placebo). Analyses will combine opposed and unopposed estrogen treatments into a single group and compare them to placebo. Patients will be followed over a 3-year (36 months) period, and will be examined at 6 month intervals to assess compliance, adverse events and general health status. Annual complete medical, gynecological, neuropsychological and functional assessments will occur during followup. Outcome measures will include dementia and memory decline. An intent-to-treat analysis will be used. Safety evaluations will be based on findings from annual assessments and reported adverse events. Participants who become demented will be informed of standard-of-care treatment and will continue to be followed at annual intervals for the length of the study.
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