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.

患有阿尔茨海默病（AD）的患者在情景记忆测试中表现出表现下降， 在医生发现症状之前十多年，执行功能和注意力 或家庭的表现下降率是正在进行的临床试验的主要结果指标。 评估旨在延迟 AD 发病的干预措施然而，当前的临床试验依赖于以下措施。 “纸笔”认知测试是手动管理和评分的，成本高、效率低、受制于 考官偏见，未能全面记录和量化测试表现。 持证审查员数量有限，人工测试将越来越不能满足需求 随着人口老龄化，认知评估可以帮助满足这一需求。 提高认知测试的敏感性、效率、全面性和客观性 商业测试电池缺乏“黄金标准”手动评估的灵敏度、有效性和可靠性 现在用于临床试验，在这个“快速通道”应用中，我们建议加强计算机化测试。 加州认知评估电池 (CCAB)，一套经过经验验证的计算机化版本的“黄金” 标准”手动测试比手动测试更高效、可靠、客观和精确。 部门，同时提供更详细、更全面、更易于访问的档案记录 然后我们将测试增强的 CCAB 对认知纵向的敏感性。 老年人的认知能力下降，包括根据 APOE 认知能力下降风险增加的人 在第一阶段，我们将重组个人 CCAB 测试，以便在平板电脑和平板电脑上进行自我管理。 添加自动语音识别以客观地对言语反应进行评分并测量言语反应 我们还将整合远程医疗功能，使检查人员能够与患者互动 在第二阶段，我们将开发一个安全、加密的数据库用于托管。 并分析匿名数据，我们将比较 CCAB 测试和等效手动测试的性能， 并开发回归函数，将 CCAB 分数转换为等效的手动测试分数，以及 最后，我们将评估 CCAB 测试对 420 名有薪老年人认知能力下降的敏感性。 我们将在两年内每隔六个月对志愿者进行一次测试，以确定基线表现。 措施，包括实践效果（重复测试时发生的附带改进），预测 具有或不具有 AD 基因型危险因素的个体随后的认知能力下降。 创建 CCAB 许可和数据管理工具，为研究人员提供免费访问 CCAB 测试和 4 年 SBIR 期间的匿名数据摘要：加州认知的增强版本。 评估电池（CCAB）将降低成本，扩大范围，并提高年龄测试的灵敏度 有AD风险的患者的相关认知能力下降。