FLAME: A computerized neuropsychological composite for trials in early dementia

Abstract

Abstract 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
• clinical trials
• early dementia
• MCI
• PROTECT
• sample size