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. 2024 Aug;20(8):5089-5101.
doi: 10.1002/alz.13757. Epub 2024 Jul 4.

Novel measures of cognition and function for the AD spectrum in the Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD) project: Psychometric properties, convergent validation, and contrasts with established measures

Hyun Kim  1   2 , Seonjoo Lee  2   3   4 , Alina Levine  4 , Benjamin Huber  4 , Howard Andrews  1   3 , Nancy A Kerner  1   2 , Daniel Cohen  2 , Scott Carlson  2 , Sophie A Bell  2 , Andres M Rivera  5 , Marc L Gordon  6 , Sabrina Simoes  5 , Davangere P Devanand  1   2   5 , Adam M Brickman  5 , Lon S Schneider  7 , Philip D Harvey  8 , Terry E Goldberg  1   2   9
Affiliations

Novel measures of cognition and function for the AD spectrum in the Novel Measures for Alzheimer's Disease Prevention Trials (NoMAD) project: Psychometric properties, convergent validation, and contrasts with established measures

Hyun Kim et al. Alzheimers Dement. 2024 Aug.

Abstract

Introduction: This study derived composite scores for two novel cognitive measures, the No Practice Effect (NPE) battery and the Miami Computerized Functional Skills Assessment and Training system for use in early-stage Alzheimer's disease (AD) clinical trials. Their psychometric properties and associations with AD risk markers were compared to those of well-established measures.

Methods: For 291 older adults with healthy cognition or early mild cognitive impairment, Exploratory factor analyses were used to identify the factor structure of the NPE. Factor and total scores were examined for their psychometric properties and associations with AD risk biomarkers.

Results: Composite scores from the novel cognitive and functional measures demonstrated better psychometric properties (distribution and test-retest reliability) and stronger associations with AD-related demographic, genetic, and brain risk markers than well-established measures, DISCUSSION: These novel measures have potential for use as primary cognitive and functional outcomes in early-stage AD clinical trials.

Highlights: Well-established cognitive tests may not accurately detect subtle cognitive changes. No Practice Effect (NPE) and Computerized Functional Skills Assessment and Training are novel measures designed to have improved psychometric properties. NPE had Executive Function, Cognitive Control/Speed, and Episodic Memory domains. Novel measures had better psychometric properties compared to established measures. Significant associations with Alzheimer's disease biomarkers were found with novel measures.

Keywords: Alzheimer's disease; clinical trial methodology; practice effects; psychometrics.

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Conflict of interest statement

A.L., B.H., A.B., D.C., S.C., S.A.B., A.M.R., S.S. have none to report. H.K. receives consulting fees from YBrain. M.L.G. reports grants from Alector, Janssen, Novo Nordisk, AbbVie, and Eisai. M.L.G. reports providing expert testimony for Wilson, Elser, Moskowitz, Edelman & Dicker and Morgan and Morgan and participating on data safety advisory boards for Labcorp and Corium. D.P.D. reports participation on a monitoring board for Acadia, BioXcel, Corium and TauRx. L.S.S. reports consulting fees from AC Immune, Alpha‐cognition, Athira, Corium, Merck, Neurim Ltd., Roche/Genentech, Lighthouse, and ImmunoBrain, Lid. A.M.B. reports receiving consulting fees from Cogstate and Cognito Therapeutics, issued and pending patents, serving in the monitoring or advisory board for Albert Einstein College of Medicine and University of Illinois, Urbana‐Champaign, serving as a section editor for Alzheimer's and Dementia. L.S.S. receives support for attending meetings from Della Martin Foundation and participates on Advisory Boards for Merck, Genentech and UCB. P.D.H. reports grants from NIMH, and the US Department of Veterans Affairs. P.D.H. reports royalties from WCG Endpoint Solutions. P.D.H. reports consulting fees and support for attending meetings from Alkermes, Boehringer‐Ingelheim, Karuna Therapeutics, Minerva Neurosciences, Roche Pharma, Sunovion/DSP Pharma/Angelini. P.D.H. reports editorial fees from Elsevier BV. P.D.H. reports stock in i‐Functions and software access from Brain HQ. Author disclosures are available in the supporting information.

Figures

FIGURE 1
FIGURE 1
EFA model of the cognitive structures in the NPE Battery. EFA, exploratory factor analysis; NPE, no practice effect; RMT, Recognition Memory Test.
FIGURE 2
FIGURE 2
Performance on novel cognitive measures by APOE4 and cognitive status. Higher scores on the CFAS Average Time of Completion, ADAS‐Cog, and FAQ indicate poorer performance. ADAS‐Cog11, Alzheimer's Disease Assessment Scale–Cognitive Subscale; APOE4, apolipoprotein E4; CFAS, Miami computerized functional assessment system; MMSE, Mini‐Mental State Exam; FAQ, Functional Activities Questionnaire; NPE, No Practice Effect battery; RMT, Recognition Memory Test; WMS, Wechsler Memory Scale.
See this image and copyright information in PMC

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