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.

项目摘要摘要当前项目的主要目标是1）评估PACR AD认知的长期疗效最初10周培训后5年，训练（PACR-CT）测量，2）从最初的培训完成5年后，助推器培训10周的疗效，3）重新设计 PACR-CT用于最佳培训时间表，以维持和潜在地增长计划的收益。与主动对照（休闲游戏）相比，我们将检查长时间的PACR-CT疗效通过比较1）认知和功能性能的培训，2）结构（白质完整性和大脑体积）和功能性大脑变化（RSFMRI和Task-FMRI）和3）用血液评估的神经变性基于AD风险的基于生物标志物（PTAU-181）。接下来，我们将检查一般的增强功效（PRE-VS。助推器后培训）以及通过比较变更来进行最初培训与助推器培训之间的相互作用组之间的分数。最后，我们将使用“最佳助推器训练间隔”修改PACR-CT时间表根据AIM 1衡量的自然认知下降速度和性能计算得出的 AIM 2的助推器训练的10周改进。评估长期效应PACR-CT 助推器效应将用于获得该程序的FDA清除率，并将其商业化为基于证据的预防装置指示与年龄相关的认知下降。这个项目应导致开发一种新的，有力的工具，以提供有效的辅助疗法，从而导致更大在AD前人群中，对认知障碍的弹性。