Division of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, USA.
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA; Division of Mental Health Data Science, New York State Psychiatric Institute, New York, NY, USA.
Contemp Clin Trials. 2021 Jul;106:106425. doi: 10.1016/j.cct.2021.106425. Epub 2021 Apr 30.
Assessment of cognition and everyday function is essential in clinical trials for Alzheimer's disease (AD). Two novel measures of cognition (No Practice Effects (NPE) cognitive battery and Miami Computerized Functional Assessment Scale (CFAS)) were designed to have robust psychometric properties and reduced practice and ceiling effects. This study aims to evaluate if the NPE and CFAS demonstrate stronger psychometric properties and reduced practice effects compared with established measures, including the Preclinical Alzheimer Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Functional Activities Questionnaire (FAQ).
This parallel group, four-site study will randomize 320 cognitively intact adults aged 60 to 85 years to novel or well-established measures of cognition and function. All participants will receive assessments at baseline (week 0), 3-months, and 12-months, as well as a brain MRI scan and Apolipoprotein E genetic test at study entry. Analyses will determine psychometric properties of the NPE and CFAS, compare the sensitivity of measures to AD risk markers, and identify cognitive domains within the NPE.
Practice effects have been a major limitation of Alzheimer's disease clinical trials that typically assess cognitive changes over serial assessments. Detection of functional impairment in cognitively normal individuals with biomarkers for Alzheimer's disease requires instruments sensitive to very subtle functional changes. This study is intended to support the validation of two new composite measures, the NPE battery and the CFAS, which may advance clinical testing of interventions for individuals across the spectrum of early stage Alzheimer's disease.
NCT03900273.
评估认知和日常功能在阿尔茨海默病（AD）的临床试验中至关重要。两项新的认知评估方法（无练习效应（NPE）认知测试和迈阿密计算机化功能评估量表（CFAS））旨在具有强大的心理测量特性和减少练习效应和天花板效应。本研究旨在评估 NPE 和 CFAS 是否比已建立的评估方法（包括临床前阿尔茨海默认知综合评估（PACC）、阿尔茨海默病评估量表认知子量表（ADAS-Cog）和功能活动问卷（FAQ））具有更强的心理测量特性和减少练习效应。
这项平行组、四站点研究将随机分配 320 名认知正常的 60 至 85 岁成年人到新的或成熟的认知和功能评估方法中。所有参与者将在基线（第 0 周）、3 个月和 12 个月进行评估，以及在研究入组时进行脑 MRI 扫描和载脂蛋白 E 基因测试。分析将确定 NPE 和 CFAS 的心理测量特性，比较评估方法对 AD 风险标志物的敏感性，并确定 NPE 中的认知域。
练习效应一直是阿尔茨海默病临床试验的主要限制因素，这些临床试验通常会在连续评估中评估认知变化。使用针对阿尔茨海默病的生物标志物来检测认知正常个体的功能障碍需要对非常细微的功能变化敏感的仪器。本研究旨在支持两项新的综合评估方法（NPE 测试和 CFAS）的验证，这可能会促进针对早期阿尔茨海默病各个阶段个体的干预措施的临床测试。
NCT03900273。
