Alzheimer's Disease Cooperative Study

阿尔茨海默病合作研究

• 批准号: 9527225
• 负责人: Howard Feldman
• 金额: $ 10万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9527225
• 关键词: Adrenergic Agents; Affect; Age; Aging; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid; Attention; Behavior assessment; Behavioral Symptoms; Biostatistics Core; Biotechnology; Clinical Course of Disease; Clinical Trials; Clinical Trials Design; Cognition; Collaborations; Controlled Clinical Trials; Data; Data Analyses; Data Set; Dementia; Development; Device or Instrument Development; Disease; Disease Progression; Drug Industry; Drug Kinetics; Enrollment; Epidemic; Epidemiology; Europe; Exercise; Family; Funding; Goals; Grant; Healthcare; Home environment; Individual; Industry; Intervention; Intervention Studies; Laboratory Study; Link; Methodology; Methods; Minority Enrollment; Minority Groups; Minority Recruitment; Modeling; Multicenter Trials; Patient Outcomes Assessments; Pharmacodynamics; Pharmacologic Substance; Pharmacological Treatment; Phase; Placebos; Population; Prazosin; Prevention; Privatization; Process; Publications; Recruitment Activity; Research; Research Design; Research Methodology; Research Personnel; Resources; Risk; Safety; Sampling Studies; Site; Testing; Therapeutic; Therapeutic Trials; Underrepresented Minority; Work; actigraphy; base; cognitive change; computerized; cooperative study; data sharing; design; effective therapy; experience; improved; innovation; instrument; mild cognitive impairment; minority subjects; neuroimaging; non-demented; novel; outreach; phase 2 study; pre-clinical; prevent; programs; symptom treatment; therapy development; trial design

The overall aim of the ADCS is to advance research in the development of interventions that might be useful for treating, delaying, or preventing AD, particularly interventions that might not be developed by industry. In particular, the ADCS "has focused on instrument and trial methodology, and the testing of potential therapeutics that might not otherwise be studied by the pharmaceutical industry. For the coming grant cycle, the ADCS will continue its efforts to advance therapeutics through controlled clinical trials, development o novel instruments and trial designs, recruitment efforts (with particular attention to recruitment f minority subjects). The organization will continue its recent emphasis on collaboration and data sharing. Specific Aims: Aim 1: Test interventions to Improve cognition, slow the rate of decline, or delay/prevent the onset of AD. Three of the four projects in this application aim to slow disease progression. Aim 2: Test an intervention to ameliorate behavioral symptoms. We will extend promising early results supporting an adrenergic approach amelioration of behavioral symptoms with a multicenter trial of prazosin. Aim 3: Design new instruments for use in clinical trials. For the present cycle, we have incorporated instrument development into our largest project, the A4 trial. Aim 4: Develop novel and innovative approaches to AD clinical trial design. The A4 trial utilizes a new trial design to test a leading intervention at the earliest feasible stge of disease, preclinical AD. Aim 5: Develop novel and innovative approaches to AD clinical trial analysis. The Biostatistics Core will continue efforts to advance analytical approaches to AD trial design. Work will continue on optimal modeling of longitudinal data, including novel methods to link diverse datasets. Aim 6:.Expand the range of individuals studied in AD studies to include at-risk individuals and those with MCI. The ADCS has focused its methodological research on early-stage trials, and for this cycle, the two largest projects target preclinical AD and mild cognitive impairment. Aim 7: Enhance the recruitment of minority groups into AD studies. For the coming cycle, the ADCS Minority Recruitment Core will expand outreach efforts, and we will require sites to meet minority enrollment targets in our two largest trials.

ADCS的总体目标是推进干预措施的研究，这些干预措施可能有助于治疗、延迟或预防AD，特别是行业可能不会开发的干预措施。特别是，ADCS“专注于仪器和试验方法，以及可能不会被制药行业研究的潜在疗法的测试。在下一个资助周期，ADCS将继续努力通过对照临床试验，开发新的仪器和试验设计，招募工作（特别注意招募少数民族受试者）来推进治疗。本组织将继续其最近对协作和数据共享的重视。具体目标：目标1：测试干预措施，以改善认知，减缓下降速度，或延迟/预防AD的发作。该申请中的四个项目中有三个旨在减缓疾病进展。目的2：测试改善行为症状的干预措施。我们将扩大有希望的早期结果支持肾上腺素能的方法改善行为症状的多中心试验哌唑嗪。目标3：设计用于临床试验的新仪器。对于本周期，我们已将仪器开发纳入我们最大的项目A4试验。目的4：开发新的和创新的方法，AD临床试验设计。A4试验采用新的试验设计，在疾病的最早可行阶段（临床前AD）测试领先的干预措施。目标5：开发新颖和创新的AD临床试验分析方法。生物统计学核心将继续努力推进AD试验设计的分析方法。将继续研究纵向数据的最佳建模，包括链接不同数据集的新方法。目标6：扩大AD研究的个体范围，包括高危个体和MCI患者。ADCS将其方法学研究集中在早期试验上，在这个周期中，两个最大的项目针对临床前AD和轻度认知障碍。目标7：加强招募少数群体参与反倾销研究。在下一个周期，ADCS少数族裔招募核心将扩大外展工作，我们将要求研究中心在我们两项最大的试验中达到少数族裔招募目标。