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: 10017118
• 负责人: Peter Pebler
• 金额: $ 91.7万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017118
• 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; 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; symposium; 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， 执行功能和注意力在症状变得明显之前超过十年 或者家人这种性能下降的速率是正在进行的临床试验中的主要结局指标 评估旨在延迟AD发病的干预措施。然而，目前的临床试验依赖于来自 人工管理和评分的“纸笔”认知测试，成本高，效率低， 考官偏见，未能全面记录和量化测试表现。此外，由于 由于有执照的考官数量有限，人工考试将越来越无法满足考试需求， 随着人口老龄化，认知评估。尽管计算机化测试有助于满足这一需求， 提高认知测试的敏感性、效率、全面性和客观性， 商业测试电池缺乏“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。在这项“快速通道”申请中，我们建议加强 加州认知评估成套测验（CCAB）是一套经过实验验证的计算机化“金牌”测验， 标准”手动测试。CCAB测试比手工测试更高效、可靠、客观、准确 同时提供更详细、更全面和更容易获得的档案记录， 纵向试验性能然后，我们将测试增强的CCAB对纵向认知的敏感性， 老年人的认知能力下降，包括基于APOE的认知能力下降风险增加的人群 基因型在第一阶段，我们将调整个人CCAB测试，以便在片剂上进行自我管理， 添加自动语音识别功能，以客观地对言语反应进行评分并测量言语反应 轻泻药。我们还将纳入远程医疗能力，使检查人员能够与病人互动， 在远程站点管理测试。在第二阶段，我们将开发一个安全、加密的数据库， 分析匿名数据。我们将比较CCAB测试和等效手动测试的性能， 开发回归函数，将CCAB分数转换为等效的手动测试分数， 亦然最后，我们将评估CCAB测试对420名老年人认知能力下降的敏感性。 志愿者，在两年的时间里每隔六个月进行一次测试。我们将确定基准性能 测量，包括实践效果（重复测试时发生的偶然改进），预测 在有和没有AD基因型危险因素的个体中随后的认知能力下降。此外，我们将 创建CCAB许可和数据管理工具，为研究人员提供免费的CCAB测试， 4年SBIR期间的匿名数据。摘要：加州认知的增强版本 评估组合（CCAB）将降低成本，扩大覆盖范围，提高年龄测试的敏感性- 与AD风险患者的认知功能下降相关。