Alzheimer's Disease Cooperative Study

阿尔茨海默病合作研究

• 批准号: 9021933
• 负责人: William C Mobley
• 金额: $ 9.96万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9021933
• 关键词: Adrenergic Agents; Affect; Age; Aging; Alzheimer' s Disease; 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; Laboratory Study; Link; Methodology; Methods; Minority; Minority Enrollment; Minority Groups; Modeling; Multicenter Trials; Patient Outcomes Assessments; Pharmacodynamics; Pharmacologic Substance; Pharmacological Treatment; Phase; Placebos; Population; Prazosin; Prevention; Process; Publications; Research; Research Design; Research Personnel; Resources; Risk; Safety; Sampling Studies; Site; Staging; Testing; Therapeutic; Therapeutic Trials; Underrepresented Minority; Work; actigraphy; adrenergic; base; cognitive change; computerized; cooperative study; data sharing; design; effective therapy; experience; improved; innovation; instrument; meetings; mild cognitive impairment; minority subjects; neuroimaging; novel; outreach; phase 2 study; pre-clinical; prevent; programs; 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 的总体目标是推进可能有助于治疗、延迟或预防 AD 的干预措施的研究，特别是工业界可能无法开发的干预措施。特别是，ADCS“重点关注仪器和试验方法，以及制药行业可能不会研究的潜在治疗方法的测试。在即将到来的资助周期中，ADCS 将继续努力通过对照临床试验来推进治疗方法、开发新仪器和试验设计、招募工作（特别关注少数群体受试者的招募）。 具体目标： 目标 1：测试干预措施以提高认知能力，减缓速度。的衰退，或该申请的四个项目中的三个旨在减缓疾病进展。目标 2：测试改善行为症状的干预措施，以支持通过多中心的肾上腺素能方法改善行为症状。目标 3：设计用于临床试验的新仪器 在本周期中，我们已将仪器开发纳入我们最大的项目 A4 试验中。目标 4：开发 AD 临床试验设计的新颖和创新方法。 A4 试验采用新的试验设计来测试疾病的最早可行阶段（临床前 AD）的主要干预措施。目标 5：开发 AD 临床试验分析的新颖和创新方法。生物统计学核心将继续努力推进 AD 试验设计的分析方法。纵向数据的优化建模工作将继续进行，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，将高危个体和 MCI 患者纳入其中。 ADCS 将其方法学研究重点放在早期试验上，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 AD 研究中少数群体的招募。在下一个周期中，ADCS 少数族裔招募核心将扩大外展工作，我们将要求站点在我们两个最大的试验中达到少数族裔招生目标。