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
...
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 AD according to the 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.