Effects of Botanicals on Cognition in Midlife Women

描述(申请人提供)：这项研究计划的广泛、长期目标是更好地了解激素疗法(HT)和替代植物补充剂对绝经后早期女性认知和大脑功能的影响。这项研究项目的具体目的是量化和比较植物绝经疗法--黑升麻和红三叶草，以及标准羟色胺、Prempro(R)(结合的马类雌激素和甲羟孕酮醋酸酯)--对神经心理和神经成像结果的影响。建议的设计是一项随机、双盲、安慰剂对照的临床试验。这项认知研究是美国国立卫生研究院资助的第二阶段随机、双盲、安慰剂对照研究的辅助研究，目的是确定黑升麻、红三叶草和Prempro(R)在治疗潮热方面的疗效。每项研究的参与者将包括多达28名女性--安慰剂、Prempro(R)、黑升麻和红三叶草--总人数高达112人。主要的结果衡量标准将是标准化神经心理测试的分数和言语记忆过程中大脑激活的模式 测试。在治疗之前和12个月的治疗期结束时，参与者将完成一组1.5小时的神经心理测试，这些测试在之前的研究中已被证明对高血压和更年期症状的影响很敏感。一半的参与者(n=60)还将在12个月的治疗期之前和之后使用功能磁共振成像(FMRI)完成神经成像评估。在核磁共振扫描仪中执行的任务将是中年女性对羟色胺敏感的言语和图形记忆任务。大脑激活模式(即区域血流变化)的组间差异的发现将指向大脑区域，这些区域有助于任何与治疗相关的记忆能力的改善。最近发现的与Prempro相关的重大健康风险增加了研究更年期症状替代疗法对认知结果影响的必要性。

DESCRIPTION (provided by applicant): The broad, long-term objective of this program of research is to better understand the effects of hormone therapy (HT) and alternative botanical supplements on cognition and brain functioning in early postmenopausal women. The specific aims of this research project are to quantify and compare the effects of the botanical menopausal treatments, black cohosh and red clover, and standard HT, Prempro (r) (conjugated equine estrogen plus medroxyprogesterone acetate), on neuropsychological and neuroimaging outcomes. The proposed design is a randomized, double-blind, placebo-controlled clinical trial. The cognitive study is conducted as an ancillary study to the NIH-funded study, A Phase II, Randomized, Double -Blind, Placebo-Controlled Study to Determine the Efficacy of Black Cohosh, Red Clover and Prempro(r) in the Management of Hot Flashes. Participants will include up to 28 women in each study arm - placebo, Prempro(r), black cohosh, and red clover - for a total n of up to 112. The primary outcome measures will be scores on standardized neuropsychological tests and patterns of brain activation during performance of verbal memory tests. Before treatment and at the end of the 12-month treatment period, participants will complete a 1.5- hour battery of neuropsychological tests that have been shown in previous studies to be sensitive to the effects of HT and menopausal symptoms. Half of the participants (n = 60) will also complete neuroimaging assessments using functional magnetic resonance imaging (fMRI) before and after the 12-month treatment period. The tasks performed in the MRI scanner will be verbal and figural memory tasks shown to be sensitive to HT in midlife women. Findings of group differences in the patterns of brain activation (i.e., regional blood flow changes) will point to the brain areas subserving any treatment-related improvements in memory performance. Recent findings of significant health risks associated with Prempro heighten the need for research into the effects of alternative therapies for menopausal symptoms on cognitive outcomes.