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June 18, 1997

Evaluating Estrogen for Alzheimer Disease Poses Ethical and Logistical Challenges

JAMA. 1997;277(23):1831-1833. doi:10.1001/jama.1997.03540470013006

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RESEARCHERS who design or conduct treatment or prevention trials for Alzheimer disease (AD) are facing some logistical difficulties and sticky ethical dilemmas. This is especially so for placebocontrolled trials that seek to determine whether estrogen can prevent or treat AD and other dementias.

Although laboratory and epidemiologic studies and several small clinical trials suggest that estrogen may help prevent AD and may even improve cognitive function in women with dementia, most experts agree that randomized, double-blind, placebo-controlled trials are needed to establish the benefits and risks of the hormone used for this purpose. Two such national trials are now under way. Both have had trouble recruiting patients, and both raise questions about the ethics of giving postmenopausal women a placebo instead of a hormone that many physicians and patients believe may prevent morbidity and mortality.

Although the evidence that estrogen helps prevent bone loss in postmenopausal women is fairly convincing,