EFFECTS OF HORMONE THERAPY ON DEVELOPMENT & PROGRESSION ON DEMENTIA

本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）试验的约8311名65岁及以上妇女（所有地点）与痴呆相关症状的发生和进展的影响。35名女性在温斯顿-塞勒姆WHI网站注册。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，此后六年每年一次。屏幕由修改的迷你精神状态（3MS）检查组成。根据参与者的得分，大约20%（代表约88%的3MS敏感性）继续进行痴呆诊断的第二阶段研究。第II阶段评估由一名认证技术人员进行，包括：神经心理测试和简短的神经精神评估，以及关于身体功能的信息数据。电池大约需要两个小时来完成和评分。第三阶段包括与精神科医生的标准化访谈。在回顾II期和III期的数据后，临床医生做出一个临时的诊断印象，要么是可能的痴呆，要么是轻微的认知障碍，要么不是痴呆。该研究的第四阶段包括在第三阶段确定为患有全因痴呆的妇女收集的所有实验室数据。检查由当地实验室进行，结果由临床医生审查，以便作出鉴别诊断。预计这些女性中约有60%将被诊断患有阿尔茨海默氏症相关的痴呆症，其余40%属于其他类型的痴呆症。一旦一名女性被确定患有痴呆症，在整个研究过程中，她将继续接受I期和II期测试，以评估症状的进展。所有的诊断和分类数据被发送到一个由具有痴呆症专业知识的临床医生组成的评审小组。据推测，与安慰剂相比，接受积极激素治疗的女性与痴呆相关的症状会延迟出现。第一期、第二期及第四期将在粤港澳中心进行。

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.