EFFECTS OF HORMONE THERAPY ON DEVELOPMENT & PROGRESSION ON DEMENTIA

这项研究旨在评估激素替代疗法对参与妇女健康倡议(WHI)激素替代疗法(HRT)试验的大约8,311名65岁及以上女性(所有地点)与痴呆症相关症状的发展和进展的影响。有35名女性在温斯顿-塞勒姆WHI网站注册。这项研究分为四个阶段。在第一阶段，参与者在基线时完成认知功能的初步筛查评估，此后每年进行六年。屏幕由改良的迷你精神状态(3MS)检查组成。根据参与者的分数，大约20%(相当于3MS约88%的敏感度)继续进行痴呆症诊断研究的第二阶段。第二阶段评估由经认证的技术员进行，包括：神经心理测试组合和简要的神经精神评估，以及关于身体功能的告密者数据。电池大约需要两个小时才能完成并得分。第三阶段包括与精神病学家的标准化面谈。在审查了第二阶段和第三阶段的数据后，临床医生对可能的痴呆症、轻微的认知障碍或非痴呆症做出了临时诊断印象。这项研究的第四阶段包括收集的所有实验室数据，这些数据都是在第三阶段被确认为患有全因痴呆症的女性。这些测试由当地实验室进行，临床医生会对结果进行审查，以便做出鉴别诊断。预计这些妇女中约60%将被诊断为与阿尔茨海默氏症相关的痴呆症，其余40%属于其他痴呆症类别。一旦一名妇女被确认患有痴呆症，她将在整个研究过程中继续进行第一阶段和第二阶段测试，以评估症状进展。所有诊断和分类数据都被发送到由具有痴呆症专业知识的临床医生组成的裁决小组。据推测，与安慰剂相反，正在接受主动激素治疗的女性与痴呆症相关的症状将会延迟。第一期、第二期和第四期工程将在启德华侨城进行。

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.