FLAME: A computerized neuropsychological composite for trials in early dementia

TY - JOUR

T1 - FLAME

T2 - A computerized neuropsychological composite for trials in early dementia

AU - Brooker, Helen

AU - Williams, Gareth

AU - Hampshire, Adam

AU - Corbett, Anne

AU - Aarsland, Dag

AU - Cummings, Jeffrey

AU - Molinuevo, Jose Luis

AU - Atri, Alireza

AU - Ismail, Zahinoor

AU - Creese, Byron

AU - Fladby, Tormod

AU - Thim-Hansen, Charlotte

AU - Wesnes, Keith

AU - Ballard, Clive

N1 - Publisher Copyright: © 2020 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association

PY - 2020

Y1 - 2020

N2 - Introduction: Sensitive neuropsychological tests are needed to improve power for clinical trials in early Alzheimer's disease (AD). Methods: To develop a neuropsychological composite (FLAME – Factors of Longitudinal Attention, Memory and Executive Function), we assessed, 10,714 participants over the age of 50 from PROTECT with validated computerized assessments for 2 years. A factorial analysis was completed to identify the key cognitive factors in all participants, and further analyses examined sensitivity to change in people with stage 2/3 early Alzheimer's disease (AD) according to the US Food and Drug Administration (FDA) framework. Results: The FLAME composite score (speed of attention, accuracy of attention, memory, and executive function) distinguished between normal cognition and stage 2/3 early AD at baseline, and was sensitive to cognitive and global/functional decline over 2 years, with the potential to improve power for clinical trials. Discussion: FLAME is sensitive to change, providing a straightforward approach to reduce sample size for RCTs in early AD. Conclusion: FLAME is a useful computerized neuropsychology composite with utility for clinical trials focusing on cognition.

AB - Introduction: Sensitive neuropsychological tests are needed to improve power for clinical trials in early Alzheimer's disease (AD). Methods: To develop a neuropsychological composite (FLAME – Factors of Longitudinal Attention, Memory and Executive Function), we assessed, 10,714 participants over the age of 50 from PROTECT with validated computerized assessments for 2 years. A factorial analysis was completed to identify the key cognitive factors in all participants, and further analyses examined sensitivity to change in people with stage 2/3 early Alzheimer's disease (AD) according to the US Food and Drug Administration (FDA) framework. Results: The FLAME composite score (speed of attention, accuracy of attention, memory, and executive function) distinguished between normal cognition and stage 2/3 early AD at baseline, and was sensitive to cognitive and global/functional decline over 2 years, with the potential to improve power for clinical trials. Discussion: FLAME is sensitive to change, providing a straightforward approach to reduce sample size for RCTs in early AD. Conclusion: FLAME is a useful computerized neuropsychology composite with utility for clinical trials focusing on cognition.

KW - Alzheimer's

KW - clinical trials

KW - early dementia

KW - MCI

KW - PROTECT

KW - sample size

UR - http://www.scopus.com/inward/record.url?scp=85100544510&partnerID=8YFLogxK

U2 - 10.1002/dad2.12098

DO - 10.1002/dad2.12098

M3 - Article

AN - SCOPUS:85100544510

SN - 2352-8729

VL - 12

JO - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring

JF - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring

IS - 1

M1 - e12098

ER -