FLAME: A computerized neuropsychological composite for trials in early dementia

Area of Science:

• Neuroscience
• Cognitive Psychology
• Clinical Trials

Background:

• Sensitive neuropsychological tests are crucial for enhancing the statistical power of clinical trials in early Alzheimer's disease (AD).
• Current assessments may lack the sensitivity required to detect subtle cognitive changes in the early stages of AD.

Purpose of the Study:

• To develop and validate a novel neuropsychological composite, FLAME (Factors of Longitudinal Attention, Memory and Executive Function).
• To assess the sensitivity of FLAME to cognitive change in individuals with early Alzheimer's disease (AD).

Main Methods:

• A large cohort of 10,714 participants over 50 from the PROTECT study were assessed using computerized cognitive tests over two years.
• Factorial analysis was employed to identify key cognitive factors, followed by sensitivity analyses in participants with stage 2/3 early AD.

Main Results:

• The FLAME composite score, encompassing attention speed and accuracy, memory, and executive function, effectively differentiated normal cognition from early AD at baseline.
• FLAME demonstrated sensitivity to both cognitive and global/functional decline over the two-year study period.
• The composite showed potential for improving statistical power in clinical trials for early AD.

Conclusions:

• FLAME is a sensitive and straightforward computerized neuropsychological composite for assessing change in early Alzheimer's disease.
• This tool offers utility for clinical trials focused on cognitive outcomes in AD, potentially reducing required sample sizes.