Novel Detection of Early Cognitive and Functional Impairment in the Elderly

老年人早期认知和功能障碍的新检测

基本信息

批准号：
8806184
负责人：
DAVID LOEWENSTEIN
金额：
$ 58.24万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-02-01 至 2020-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8806184
关键词：
Affect Age Alzheimer&apos s Disease Alzheimer&apos s disease risk Amyloid Atrophic Biological Markers Brain Clinical Clinical Research Clinical Trials Clinical assessments Cognitive Cognitive deficits Computers Cues Dementia Detection Diagnosis Diagnostic Disease Early Diagnosis Early treatment Education Effectiveness Elderly Event Exhibits Family Guidelines Health education Hippocampus (Brain)Hispanics Home environment Impaired cognition Impairment Independent Living Individual Intervention Investigation Language Learning Longitudinal Studies Magnetic Resonance Imaging Measures Medial Medication Management Not Hispanic or Latino Outcome Outpatients Participant Patients Performance Physicians Readiness Relative (related person)Risk Sampling Semantics Sensitivity and Specificity Series Staging Structure Symptoms Technology Testing Time Validity and Reliability Work base cognitive testing design diagnostic accuracy flexibility follow-up functional decline functional disability high risk innovation instrument meetings mild cognitive impairment neuroimaging neuropsychological novel pre-clinical prospective memory public health relevance remediation research clinical testing response simulation tau Proteins tau-1 treatment center

项目摘要

DESCRIPTION (provided by applicant): There is growing recognition that conditions such as Alzheimer's disease (AD) occur years before a formal diagnosis is rendered and that available cognitive and functional assessment measures are not sufficiently sensitive to detect early changes associated with the condition. This is critical since new treatment approaches are likely to be most effective in the earliest stages of disease. Further, FDA guidelines indicate that changes in biomarker measures will not be considered as surrogate outcomes in clinical trials of emerging therapies for early AD, unless they are also shown to have a clinical impact. The proposed investigation is highly innovative and designed to examine the efficacy of the newly developed and novel cognitive tests of cued recall and semantic interference (LASSI-L), time and event related prospective memory (MPMT), and novel computer-based functional task simulations (FTS) in detecting subtle cognitive and functional impairments, and progression of these impairments over time. Our sample will include Spanish-speaking and English-speaking older adults diagnosed with traditional neuropsychological measures and clinical evaluations as: amnestic MCI (aMCI), pre-clinical MCI (PreMCI), or cognitively normal (NC). In the proposed investigation, we will further establish the reliability and validity of our novel cognitive and functional measures in distinguishing between diagnostic groups and predicting progression of cognitive and functional decline over time. We also predict that among aMCI and PreMCI subjects, baseline and change scores on the LASSI-L, MPMT, and FTS will exhibit stronger associations with increasing MRI atrophy over a minimum three-year period relative to traditional neuropsychological measures. An exciting exploratory aim of the study will be the exploration, among a subsample of PreMCI and aMCI participants, the association between amyloid, tau, and phosphorylated tau biomarker levels in the CSF and performance on the LASSI-L, MPMT and FTS.

描述（由申请人提供）：人们越来越认识到，阿尔茨海默病 (AD) 等疾病在正式诊断前数年就已发生，并且现有的认知和功能评估措施不够灵敏，无法检测与该疾病相关的早期变化。至关重要，因为新的治疗方法可能在疾病的早期阶段最有效。此外，FDA 指南表明，生物标志物测量的变化不会被视为早期 AD 新兴疗法临床试验的替代结果，除非它们也被认为是替代结果。已显示出具有临床影响。拟议的研究具有高度创新性，旨在检验新开发的新颖的线索回忆和语义干扰认知测试（LASSI-L）、时间和事件相关的前瞻性记忆（MPMT）以及新颖的基于计算机的功能任务模拟的有效性(FTS) 来检测细微的认知和功能障碍，以及这些障碍随时间的推移的进展。我们的样本将包括通过传统神经心理学测量和临床评估诊断为西班牙语和英语的老年人：遗忘性 MCI (aMCI)、临床前 MCI (PreMCI) 或认知正常 (NC) 在拟议的研究中，我们将进一步确定我们的新型认知和功能测量在区分诊断组和预测认知和功能随时间下降的进展方面的可靠性和有效性。我们还预测，在 aMCI 和 PreMCI 受试者中，与传统的神经心理学测量相比，LASSI-L、MPMT 和 FTS 的基线和变化评分将在至少三年内与 MRI 萎缩的增加表现出更强的关联。该研究令人兴奋的探索性目标是在 PreMCI 和 aMCI 参与者的子样本中探索 CSF 中淀粉样蛋白、tau 蛋白和磷酸化 tau 生物标志物水平与 LASSI-L、MPMT 和 FTS 表现之间的关联。