Phase IIB Plasticity-based Adaptive Cognitive Remediation for Alzheimers Disease

IIB 期基于可塑性的阿尔茨海默病自适应认知疗法

基本信息

批准号：
10603717
负责人：
Hyun Kyu Lee
金额：
$ 92.49万
依托单位：
POSIT SCIENCE CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-30 至 2026-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10603717
关键词：
Adult Age Age-associated memory impairment Alzheimer disease prevention Alzheimer&apos s Disease Alzheimer&apos s disease related dementia Alzheimer&apos s disease risk American Assessment tool Brain Chronology Cognition Cognitive Cognitive remediation Collaborations Conduct Clinical Trials Dementia Development Devices Economic Burden Effectiveness Elderly Enrollment Epidemiology Evaluation Follow-Up Studies Functional Magnetic Resonance Imaging Goals Home Hour Impaired cognition Individual Internet Interval training Iowa Longevity Maintenance Measures Mediating Modeling Monitor Nerve Degeneration Nervous System Physiology Neuronal Plasticity Outcome Participant Pathology Performance Pharmacotherapy Phase Phase II Clinical Trials Play Population Prevention Randomized Schedule Source Standardization Structure Testing Texas Therapeutic Time Training Training Programs Universities active control age effect blood-based biomarker brain health brain volume cognitive ability cognitive function cognitive performance cognitive rehabilitation cognitive testing cognitive training commercialization comparative efficacy computerized design efficacy evaluation evidence base follow up assessment follow-up improved information processing neurobehavioral novel phase I trial phase II trial processing speed programs recruit resilience social study population tool white matter

项目摘要

Project Summary Abstract The primary objectives of the current project are 1) to evaluate the longer-term efficacy of PACR-AD cognitive training (PACR-CT) measured 5 years after the completion of initial 10 weeks of training, 2) to determine the efficacy of the 10 weeks of booster training after 5 years from the initial training completion, and 3) to redesign the PACR-CT for optimal training schedule to sustain and potentially further-grow program-delivered benefits. We will examine prolonged PACR-CT efficacy compared to Active Control (Casual Games) at 5 years after training by comparing 1) cognitive and functional performance, 2) structural (white matter integrity and brain volume) and functional brain changes (rsfMRI and task-fMRI) and 3) neurodegeneration assessed with blood- based biomarkers (pTau-181) predictive of AD risk. Next, we will examine the general booster efficacy (pre- vs. post-booster training), and the interaction between initial training and booster training by comparing the change scores between groups. Finally, we will modify PACR-CT schedule with the optimal booster training interval calculated based on the rate of natural cognitive decline measured from Aim 1 and the performance improvement from the 10 weeks of booster training from Aim 2. Evaluation of the longer-term effect PACR-CT and the booster effect will be used to obtain FDA clearance for the program and commercialize it as the evidence-based prevention device indicated for age-related cognitive decline. This project should result in the development of a new, and powerful tool to provide effective adjunctive therapy that results in far greater resilience against cognitive impairment in a substantially greater pre-AD population.

项目概要摘要当前项目的主要目标是 1) 评估 PACR-AD 认知的长期疗效培训 (PACR-CT) 在完成最初 10 周培训后 5 年进行测量，2) 以确定初始训练完成 5 年后 10 周强化训练的效果，以及 3) 重新设计 PACR-CT 制定最佳培训计划，以维持并可能进一步增加计划带来的效益。我们将在 5 年后检查 PACR-CT 与 Active Control（休闲游戏）相比的长期疗效通过比较 1) 认知和功能表现，2) 结构（白质完整性和大脑）进行训练体积）和功能性大脑变化（rsfMRI 和任务 fMRI）和 3）用血液评估神经退行性变基于生物标志物 (pTau-181) 的 AD 风险预测。接下来，我们将检查一般加强剂功效（治疗前与治疗后）。后助推器训练），以及通过比较变化来初始训练和助推器训练之间的相互作用组间得分。最后，我们将使用最佳加强训练间隔修改 PACR-CT 时间表根据目标 1 测量的自然认知衰退率和表现计算目标 2 的 10 周强化训练的改善。PACR-CT 长期效果评估助推器效应将用于获得 FDA 批准该项目并将其商业化为基于证据的预防装置适用于与年龄相关的认知能力下降。该项目应导致开发一种新的、强大的工具来提供有效的辅助治疗，从而产生更大的效果在 AD 前期人群中抵抗认知障碍的能力要大得多。