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.
Keywords: Alzheimer's; MCI; PROTECT; clinical trials; early dementia; sample size.
© 2020 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association.