Development of novel measures for Alzheimer's disease prevention trials (NoMAD).
Development of novel measures for Alzheimer's disease prevention trials (NoMAD).
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DOI：
10.1016/j.cct.2021.106425
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发表时间：
2021-07
影响因子：
2.2
通讯作者：
Goldberg, Terry E.
中科院分区：
文献类型：
--
作者：
Bell, Sophie A.;Cohen, Hannah R.;Lee, Seonjoo;Kim, Hyun;Ciarleglio, Adam;Andrews, Howard;Rivera, Andres M.;Igwe, Kay;Brickman, Adam M.;Devanand, D. P.;Harvey, Philip D.;Schneider, Lon S.;Goldberg, Terry E.
关键词：
认知和日常功能的评估在阿尔茨海默病（AD）的临床试验中至关重要。设计了两种新的认知测量方法（无练习效应（NPE）认知成套测验和迈阿密计算机功能评估量表（CFAS）），以具有强大的心理测量特性并减少练习和天花板效应。本研究旨在评估NPE和CFAS是否表现出更强的心理测量特性，并与已建立的措施相比，减少实践效果，包括临床前阿尔茨海默氏症认知综合征（PACC），阿尔茨海默氏症评估量表-认知子量表（ADAS-Cog）和功能活动问卷（FAQ）。这项平行组，四个地点的研究将随机选择320名年龄在60至85岁之间的认知功能完好的成年人，进行新的或完善的认知和功能测量。所有受试者将在基线（第0周）、3个月和12个月时接受评估，并在进入研究时接受脑部MRI扫描和载脂蛋白E基因检测。分析将确定NPE和CFAS的心理测量特性，比较AD风险标志物测量的敏感性，并确定NPE内的认知领域。实践效果一直是阿尔茨海默病临床试验的主要限制，这些临床试验通常评估认知变化而不是系列评估。在具有阿尔茨海默病生物标志物的认知正常个体中检测功能障碍需要对非常微妙的功能变化敏感的仪器。这项研究旨在支持两个新的综合措施，NPE电池和CFAS，这可能会推进临床测试的干预措施的个人在整个频谱的早期阿尔茨海默病的验证。
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.
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DOI：
10.1016/j.jalz.2013.11.007
发表时间：
2014-11
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
Mathews M;Abner E;Kryscio R;Jicha G;Cooper G;Smith C;Caban-Holt A;Schmitt FA
通讯作者：
Schmitt FA
影响因子：
3.7
作者：
Dickerson, Bradford C.;Bakkour, Akram;Salat, David H.;Feczko, Eric;Pacheco, Jenni;Greve, Douglas N.;Grodstein, Fran;Wright, Christopher I.;Blacker, Deborah;Rosas, H. Diana;Sperling, Reisa A.;Atri, Alireza;Growdon, John H.;Hyman, Bradley T.;Morris, John C.;Fischl, Bruce;Buckner, Randy L.
通讯作者：
Buckner, Randy L.
影响因子：
29
作者：
Donohue, Michael C.;Sperling, Reisa A.;Salmon, David P.;Rentz, Dorene M.;Raman, Rema;Thomas, Ronald G.;Weiner, Michael;Aisen, Paul S.
通讯作者：
Aisen, Paul S.
影响因子：
6.4
作者：
Goldberg, T. E.;Harvey, P. D.;Gomar, Jesus J.
通讯作者：
Gomar, Jesus J.
影响因子：
11.3
作者：
FLEMING, K;GOLDBERG, TE;WEINBERGER, DR
通讯作者：
WEINBERGER, DR