This study is designed to assess the effects of hormone replacement therapy on the development and progression of symptoms associated with dementia in the approximately 8,311 women (all sites), 65 years of age and older, participating in the Hormone Replacement Therapy (HRT) trial of the Women's Health Initiative (WHI). Thirty-five women are enrolled in the Winston-Salem WHI site. The study is divided into four phases. In Phase I, the participants complete a primary screening assessment of cognitive functioning at baseline and annually thereafter for six years. The screen consists of the Modified Mini Mental State (3MS) Examination. Based on the participants' scores, approximately 20% (representing about 88% sensitivity on the 3MS) continue to Phase II of the study of the diagnosis of dementia. Phase II assessment is conducted by a certified technician and includes; neuropsychological test battery and a brief neuropsychiatric assessment, and informant data on physical functioning. The battery takes approximately two hours to complete and score. Phase III consists of a standardized interview with a psychiatrist. After reviewing data from Phase II and Phase III the clinician makes a provisional diagnostic impression of either probable dementia, minor cognitive impairment, or not dementia. Phase IV of the study includes all laboratory data collected on the women identified as having all-cause dementia in Phase III. The tests are performed by local laboratories, and the results are reviewed by the clinician in order to make a differential diagnosis. It is anticipated that about 60% of these women will be diagnosed with Alzheimer's-related dementia with the remaining 40% falling into other dementia categories. Once a woman is identified as having dementia, she continues to be followed with Phase I and Phase II testing throughout the study in order to assess symptom progression. All diagnosis and classification data are sent to an adjudication panel comprised of clinicians with expertise in dementia. It is hypothesized that the symptoms associated with dementia will be delayed in women who are on active hormone therapy, as opposed to placebo. Phases I, II and IV will be performed in the GCRC.
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