The Women's Health Initiative Memory Study (WHIMS): A trial of the effect of estrogen therapy in preventing and slowing the progression of dementia

Evidence from animal, human cross-sectional, case-control, and prospective studies indicate that hormone replacement therapy (HRT) is a promising trea tment to delay the onset of symptoms of dementia. The Women's Health initia tive Memory Study (WHIMS) is the first double-masked, randomized, placebo-c ontrolled, long-term clinical trial designed to test the hypothesis that HR T reduces the incidence of all-cause dementia in women aged 65 and older. W HIMS, an ancillary study to the Women's Health Initiative (WHI) funded by t he National Institutes of Health, will recruit a subgroup of women aged 65 and older from among those enrolling in the HRT trial of the WHI. The WHI c linical centers and 10 affiliated satellites plan to enroll approximately 8 300 women into WHIMS over a 2-year period. Participants will be followed an nually for 6 years, receiving cognitive assessments via the Modified Mini-M ental State (3MS) Examination. Women who screen positively for cognitive im pairment on the basis of an educational and age-adjusted 3MS cutpoint proce ed to more extensive neuropsychological testing and neurologic evaluation. Each woman suspected to have dementia then undergoes a series of laboratory tests that confirm the clinical diagnosis and classify the type of dementi a. WHIMS is designed to provide more than 80% statistical power to detect a 40% reduction in the rate of all-cause dementia, an effect that could have profound public health implications for older women's health and functioni ng. trolled Clinical Trials 1998;19:604-621 (C) Elsevier Science Inc. 1998.