Alzheimer's Disease: Potential Benefit of Isoflavones

阿尔茨海默病：异黄酮的潜在益处

• 批准号: 7261341
• 负责人: CAREY E GLEASON
• 金额: $ 13.52万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-15 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7261341
• 关键词: Adverse effects; Affect; Age; Alternative Therapies; Alzheimer' s Disease; American; Apolipoprotein E; Area; Basic Science; Biological Assay; Blood; Bone Density; Class; Clinical; Clinical Investigator; Clinical Research; Cognition; Cognitive; Complementary and alternative medicine; Conjugated Equine Estrogens; Data; Dementia; Development; Disease Progression; Dose; Double-Blind Method; Educational workshop; Effectiveness; Elderly; Enrollment; Environment; Epidemic; Estradiol; Estrogen Therapy; Estrogens; Ethics; Event; Exhibits; Funding; Future; Genotype; Geriatrics; Goals; Head; Healthcare; Hormone replacement therapy; Human; Impaired cognition; Individual; Innovative Therapy; Institution; Internships; Intervention; Investigation; Isoflavones; Leadership; Lipids; Malignant Neoplasms; Manufacturer Name; Medical Education; Medicine; Memory; Mentored Clinical Oncology Award; Mentored Clinical Scientist Award; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Molecular Genetics; Neurobiology; Neurocognitive; Neurosciences; Neurosecretory Systems; Numbers; Other Resources; Patients; Pharmaceutical Preparations; Phytoestrogens; Pilot Projects; Placebo Control; Placebos; Plasma; Population; Postmenopause; Prempro; Prevalence; Prevention strategy; Program Development; Property; Publishing; Randomized; Rate; Recording of previous events; Recruitment Activity; Research; Research Design; Research Project Grants; Risk; Safety; Solid; Symptoms; Therapeutic; Time; Training; United States National Institutes of Health; Universities; Venous; Visit; Wisconsin; Woman; Women' s Health; base; brain tissue; career; cerebrovascular; cognitive function; data management; day; design; interest; lectures; medical schools; men; nutrition; older women; prevent; programs; response; selective attention; soy; soy protein isolate

DESCRIPTION (provided by applicant): Candidate: My goal is to become an independent clinical investigator, specializing in the area of therapeutic and preventive strategies, targeting the neurocognitive symptoms associated with Alzheimer's disease (AD). My short-term goal is to develop an independent research career focused on phytoestrogen (soy isoflavone) interventions in particular. With this K23 award, I will dedicate 100% of my time to a career program incorporating mentorship from a committee of individuals well-versed in clinical research and mentoring; formal coursework through the University of Wisconsin's (UW) Clinical Investigator Preparatory Program (CIPP; NIH K30), the Capstone Certificate, and the Medical Education, Development, and Leadership program; formal internships; as well as seminars, lectures, and workshops. With this career plan, I will build on previous training, developing a solid scientific background in study design, ethics/responsible conduct of research, data management, and nutritional sciences of isoflavones. Environment: The UW Medical School is a premier research institution with a long history of successful mentorship, and a well-established career development program (CIPP). The UW recently identified Neuroscience and Geriatrics as two of the top five areas of development. Toward this goal, the Department of Medicine recruited Sanjay Asthana to head the Section of Geriatrics. With the arrival of Dr. Asthana, my primary mentor, this institution now has an AD research program with 14 funded investigations, and a growing reputation. Other resources I can avail upon include the General Clinical Research Center (GCRC), and the VA Geriatric, Educational and Clinical Center (GRECC). Research: This investigation examines the cognitive effects of soy isoflavones, a class of phytoestrogens, in older adults with AD. Recent findings from the Women's Health Initiative (WHI), a large trial utilizing traditional hormone replacement therapies (HRTs), have raised concerns over the feasibility of HRTs, given the increased risk of serious adverse effects, including cognitive decline. Soy isoflavones may serve as a critically-needed alternative therapy to traditional HRT. The few human research projects that have examined the neurocognitive effects of soy isoflavones offer intriguing but preliminary support for isoflavones' beneficial actions on cognition. Presently, there are no data regarding the effectiveness of isoflavones to treat AD-associated cognitive declines. Sixty older adults with AD will be enrolled in this randomized, placebo-controlled, double-blind, parallel-group design clinical study. Subjects will receive either 100mg/day of soy isoflavones or a placebo for 6 months. Cognitive data will be collected at Baseline and at 1, 3 and 6 months, post-initiation of study medications, and again 3 months after termination of treatment. In addition, blood, collected at each treatment visit, will be assayed for plasma isoflavone levels, and other neuroendocrine markers of interest.

描述（由申请人提供）：候选人：我的目标是成为一名独立的临床研究者，专门研究治疗和预防策略，针对与阿尔茨海默氏病（AD）相关的神经认知症状。我的短期目标是开发针对植物雌激素（大豆异黄酮）干预措施的独立研究生涯。 有了这个K23奖，我将100％的时间将我的职业课程献给了一项职业计划，该计划纳入了一个精通临床研究和指导的个人委员会的指导；通过威斯康星大学（UW）临床研究者预备计划（CIPP; NIH K30），CAPSTONE证书以及医学教育，发展和领导力计划的正式课程；正式实习；以及研讨会，讲座和讲习班。通过这项职业计划，我将在先前的培训中建立发展，发展研究设计，伦理/负责任的研究，数据管理和同性恋科学的扎实科学背景。 环境：西澳大学医学院是一家主要的研究机构，拥有悠久的成功指导历史，并且成熟的职业发展计划（CIPP）。西澳大学最近将神经科学和老年医学鉴定为发展的前五名领域中的两个。为了实现这一目标，医学系招募了Sanjay Asthana，以领导老年病。随着我的主要导师Asthana博士的到来，该机构现在拥有一项广告研究计划，其中有14项资助的调查和声誉越来越大。我可以利用的其他资源包括一般临床研究中心（GCRC），以及VA老年，教育和临床中心（GRECC）。 研究：这项研究检查了AD的老年人，研究了一类植物雌激素大豆异黄酮的认知作用。考虑到严重不良反应的风险增加，包括认知能力下降的风险增加，使用传统的激素替代疗法（HRT）的一项大型试验，该妇女健康计划（WHI）的最新发现引起了人们对HRT的可行性的担忧。大豆异黄酮可以作为传统HRT的急需的替代疗法。少数研究了大豆异黄酮神经认知作用的人类研究项目为异黄酮对认知的有益行动提供了有趣但初步的支持。目前，尚无有关异黄酮治疗与广告相关的认知下降的有效性的数据。这项随机，安慰剂对照，双盲，平行组设计临床研究将招募60名AD的老年人。受试者将获得100mg/天的大豆异黄酮或安慰剂6个月。认知数据将在基线和1、3和6个月，研究药物的生效后以及终止治疗后3个月收集。此外，将在每次治疗时收集的血液中收集的血浆异黄酮水平和其他感兴趣的神经内分泌标志物进行测定。