Computerized tests of cognitive decline in presymptomatic Alzheimer's disease

阿尔茨海默病症状前认知能力下降的计算机化测试

• 批准号: 10224087
• 负责人: Peter Pebler
• 金额: $ 84.81万
• 依托单位: NEUROBEHAVIORAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10224087
• 关键词: Affect; Age; Age-Years; Age-associated memory impairment; Alzheimer' s Disease; Alzheimer' s disease diagnosis; Alzheimer' s disease pathology; Alzheimer' s disease risk; American; Archives; Attention; Benchmarking; California; Clinical Trials; Code; Cognition; Cognitive; Computers; Consumption; Data; Databases; Dementia; Deterioration; Digit structure; Disease Progression; Early Diagnosis; Episodic memory; Event; Family; Genetic Risk; Genotype; Gold; Health Insurance Portability and Accountability Act; Healthcare; Impaired cognition; Individual; Intervention; Licensing; Manuals; Materials Testing; Measures; Medical; Memory; Monitor; Older Population; Onset of illness; Outcome Measure; Paper; Participant; Patient Recruitments; Patients; Performance; Phase; Physicians; Pilot Projects; Play; Population; Reaction Time; Records; Research Personnel; Response Latencies; Risk; Role; Saliva; Secure; Self Administration; Site; Small Business Innovation Research Grant; Speech; Symptoms; Systems Integration; Tablets; Technology; Test Result; Testing; Time; Training; Translating; Underserved Population; Validity and Reliability; Video Recording; Videoconferencing; apolipoprotein E-4; automated speech recognition; base; care burden; cloud based; cognitive testing; computerized; cost; data anonymization; data hosting; data management; design; encryption; executive function; improved; innovation; mental function; novel; novel therapeutics; performance tests; pre-clinical; primary outcome; processing speed; programs; research clinical testing; response; risk variant; success; testing access; therapy design; tool; urban area; usability; volunteer; web site

Patients who develop Alzheimer's disease (AD) show performance declines in tests of episodic memory, executive functioning, and attention more than a decade before symptoms become apparent to their physician or family. The rate of this performance decline is the primary outcome measure in ongoing clinical trials evaluating interventions aimed at delaying AD onset. However, current clinical trials rely on measures from “paper and pencil” tests of cognition that are manually-administered and scored, costly, inefficient, subject to examiner bias, and fail to comprehensively record and quantify test performance. Moreover, because of the limited number of licensed examiners, manual tests will be increasingly unable to meet the demand for cognitive assessments as the population ages. Although computerized tests help meet this demand by increasing the sensitivity, efficiency, comprehensiveness, and objectivity of cognitive testing, existing commercial test batteries lack the sensitivity, validity, and reliability of “gold standard” manual assessments now used in clinical trials. In this “fast-track” application, we propose to enhance the computerized tests of the California Cognitive Assessment Battery (CCAB), a set of empirically-validated, computerized versions of “gold standard” manual tests. CCAB tests are more efficient, reliable, objective, and precise than their manual-test counterparts, while providing more detailed, comprehensive, and easily accessible archival records of longitudinal test performance. We will then test the enhanced CCAB’s sensitivity to longitudinal cognitive decline in older individuals, including those at increased risk of cognitive decline based on their APOE genotype. During Phase I, we will restructure the individual CCAB tests for self-administration on tablets and add automatic speech recognition to objectively score verbal responses and measure verbal-response latencies. We will also incorporate telemedical capabilities to enable examiners to interact with patients and administer tests at remote sites. During Phase II, we will develop a secure, encrypted database for hosting and analyzing anonymized data. We will compare performance on CCAB tests and equivalent manual tests, and develop regression functions for translating CCAB scores to equivalent manual test scores, and vice versa. Finally, we will evaluate the sensitivity of the CCAB tests to cognitive decline in 420 older paid volunteers, tested at six-month intervals over a two-year period. We will identify baseline performance measures, including practice effects (incidental improvements that occur when tests are repeated), that predict subsequent cognitive decline in individuals with and without genotype risk factors for AD. In addition, we will create CCAB licensing and data-management tools to provide researchers with free access to CCAB tests and anonymized data during the 4-year SBIR. Summary: Enhanced versions of the California Cognitive Assessment Battery (CCAB) will reduce the cost, expand the reach, and improve the sensitivity of tests of age- related cognitive decline in patients at risk for AD.

发展阿尔茨海默氏病（AD）的患者在情节记忆测试中的表现下降， 执行功能，并在症状显而易见的症状显而易见的十多年 或家庭。这种绩效下降的速度是正在进行的临床试验中的主要结果指标 评估旨在延迟AD发作的干预措施。但是，当前的临床试验依赖于 “纸和铅笔”测试认知测试，这些测试是手动管理和评分，昂贵，效率低下的认知测试 考官偏见，无法全面记录和量化测试性能。而且，由于 有限数量的许可审查员，手动测试将越来越无法满足对的需求 认知评估作为人口年龄。尽管计算机测试有助于满足这一需求 提高认知测试的敏感性，效率，全面性和目标，现有 商业测试电池缺乏“金标准”手动评估的敏感性，有效性和可靠性 现在用于临床试验。在此“快速轨道”应用中，我们建议增强计算机测试 加利福尼亚认知评估电池（CCAB），一组经验验证的计算机版本的“黄金” 标准”手动测试。CCAB测试比手动测试更有效，可靠，客观和精确 同时，同时提供了更详细，更全面且易于访问的档案记录 纵向测试性能。然后，我们将测试增强的CCAB对纵向认知的敏感性 老年人的下降，包括根据APOE的认知能力下降风险增加的人 基因型。在第一阶段，我们将限制单个CCAB测试，以在平板电脑上进行自我管理 添加自动语音识别以客观地评分口头回应并测量口头响应 潜伏期。我们还将结合远程医疗功能，使检查人员能够与患者互动，并 在远程站点进行测试。在第二阶段，我们将开发一个安全的，加密的数据库用于托管 并分析了匿名数据。我们将比较CCAB测试和同等手动测试的性能， 并开发回归函数，以将CCAB分数转换为同等的手动测试评分，并逐渐 Versa。最后，我们将评估CCAB测试对420个老年付费认知能力下降的敏感性 志愿者在两年期间以六个月的间隔进行测试。我们将确定基线性能 措施，包括练习效果（重复测试时发生的偶然改进），以预测 患有和没有基因型风险因素的个体的认知能力下降。此外，我们将 创建CCAB许可和数据管理工具，以为研究人员提供免费访问CCAB测试的访问权限和 4年SBIR期间的匿名数据。摘要：加利福尼亚认知的增强版本 评估电池（CCAB）将降低成本，扩大覆盖范围并提高年龄测试的敏感性 - AD风险的患者的相关认知能力下降。