Development of novel measures for Alzheimer's disease prevention trials (NoMAD)

被引：5

作者：

Bell, Sophie A. ^{[1
]}

Cohen, Hannah R. ^{[1
]}

Lee, Seonjoo ^{[2
,3
]}

Kim, Hyun ^{[1
,7
]}

Ciarleglio, Adam ^{[4
]}

Andrews, Howard ^{[2
]}

Rivera, Andres M. ^{[5
,6
]}

Igwe, Kay ^{[5
,6
]}

Brickman, Adam M. ^{[5
,6
]}

Devanand, D. P. ^{[1
,7
]}

Harvey, Philip D. ^{[8
]}

Schneider, Lon S. ^{[9
]}

Goldberg, Terry E. ^{[1
,7
]}

机构：

[1] New York State Psychiat Inst & Hosp, Div Geriatr Psychiat, New York, NY 10032 USA

[2] Columbia Univ, Dept Biostat, Mailman Sch Publ Hlth, New York, NY USA

[3] New York State Psychiat Inst & Hosp, Div Mental Hlth Data Sci, New York, NY 10032 USA

[4] George Washington Univ, Milken Inst Sch Publ Hlth, Dept Biostat & Bioinformat, Washington, DC USA

[5] Columbia Univ, Dept Neurol, Taub Inst Res Alzheimers Dis & Aging Brain, Vagelos Coll Phys & Surg, New York, NY USA

[6] Columbia Univ, Gertrude H Sergievsky Ctr, Vagelos Coll Phys & Surg, New York, NY 10027 USA

[7] Columbia Univ, Dept Psychiat, Med Ctr, New York, NY USA

[8] Univ Miami, Miller Sch Med, Miami VA Med Ctr, Miami, FL 33136 USA

[9] Univ Southern Calif, Keck Sch Med, Los Angeles, CA 90007 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2021年 / 106卷

关键词：

Alzheimer's disease; Preclinical Alzheimer's disease; Computerized assessment; Cognition; Practice effects; MILD COGNITIVE IMPAIRMENT; WORKING-MEMORY; CORTICAL SIGNATURE; SHORT-FORM; PERFORMANCE; DEMENTIA; SCHIZOPHRENIA; DECLINE;

D O I：

10.1016/j.cct.2021.106425

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Introduction: 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). Methods: 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. Discussion: 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. Trial Registration: NCT03900273

引用

页数：9

共 38 条

[21] Examining 3-month test-retest reliability and reliable change using the Cambridge Neuropsychological Test Automated Battery [J].

Karlsen, Rune H. ;

Karr, Justin E. ;

Saksvik, Simen B. ;

Lundervold, Astri J. ;

Hjemdal, Odin ;

Olsen, Alexander ;

Iverson, Grant L. ;

Skandsen, Toril .

APPLIED NEUROPSYCHOLOGY-ADULT, 2022, 29 (02) :146-154

[22] Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS) [J].

Keefe, Richard S. E. ;

Harvey, Philip D. ;

Goldberg, Terry E. ;

Gold, James M. ;

Walker, Trina M. ;

Kennel, Courtney ;

Hawkins, Kirsten .

SCHIZOPHRENIA RESEARCH, 2008, 102 (1-3) :108-115

[23] Executive function and instrumental activities of daily living in mild cognitive impairment and Alzheimer's disease [J].

Marshall, Gad A. ;

Rentz, Dorene M. ;

Frey, Meghan T. ;

Locascio, Joseph J. ;

Johnson, Keith A. ;

Sperling, Reisa A. .

ALZHEIMERS & DEMENTIA, 2011, 7 (03) :300-308

[24] Diagnostic accuracy and practice effects in the National Alzheimer's Coordinating Center Uniform Data Set neuropsychological battery [J].

Mathews, Melissa ;

Abner, Erin ;

Kryscio, Richard ;

Jicha, Gregory ;

Cooper, Gregory ;

Smith, Charles ;

Caban-Holt, Allison ;

Schmitt, Frederick A. .

ALZHEIMERS & DEMENTIA, 2014, 10 (06) :675-683

[25] Synergistic Effect of β-Amyloid and Neurodegeneration on Cognitive Decline in Clinically Normal Individuals [J].

Mormino, Elizabeth C. ;

Betensky, Rebecca A. ;

Hedden, Trey ;

Schultz, Aaron P. ;

Amariglio, Rebecca E. ;

Rentz, Dorene M. ;

Johnson, Keith A. ;

Sperling, Reisa A. .

JAMA NEUROLOGY, 2014, 71 (11) :1379-1385

[26] The uniform data set (UDS): Clinical and cognitive variables and descriptive data from Alzheimer disease centers [J].

Morris, John C. ;

Weintraub, Sandra ;

Chui, Helena C. ;

Cummings, Jeffrey ;

DeCarli, Charles ;

Ferris, Steven ;

Foster, Norman L. ;

Galasko, Douglas ;

Graff-Radford, Neill ;

Peskind, Elaine R. ;

Beekly, Duane ;

Ramos, Erin M. ;

Kukull, Walter A. .

ALZHEIMER DISEASE & ASSOCIATED DISORDERS, 2006, 20 (04) :210-216

[27] UCSD Performance-Based Skills Assessment: Development of a new measure of everyday functioning for severely mentally ill adults [J].

Patterson, TL ;

Goldman, S ;

McKibbin, CL ;

Hughs, T ;

Jeste, DV .

SCHIZOPHRENIA BULLETIN, 2001, 27 (02) :235-245

[28] Levels of processing effects on recognition memory in patients with schizophrenia [J].

Paul, BM ;

Elvevåg, B ;

Bokat, CE ;

Weinberger, DR ;

Goldberg, TE .

SCHIZOPHRENIA RESEARCH, 2005, 74 (01) :101-110

[29] MEASUREMENT OF FUNCTIONAL ACTIVITIES IN OLDER ADULTS IN THE COMMUNITY [J].

PFEFFER, RI ;

KUROSAKI, TT ;

HARRAH, CH ;

CHANCE, JM ;

FILOS, S .

JOURNALS OF GERONTOLOGY, 1982, 37 (03) :323-329

[30]

ROSEN WG, 1984, AM J PSYCHIAT, V141, P1356

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