Lilly includes a single primary endpoint of cognition (ADAS-Cog14) to EXPEDITION3 trial

Eli Lilly has announced a change to the primary endpoint for the EXPEDITION3 clinical trial, a Phase 3 study of solanezumab in people with mild Alzheimer’s dementia.

Eli Lilly headquarters

Lily says that the original study design included co-primary endpoints of cognition and function—measured by ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale) and ADCS-iADL (Alzheimer’s Disease Cooperative Study-Instrumental Activities of Daily Living), respectively. Emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline in Alzheimer’s disease, particularly in earlier stages of the disease.

Thus, . Functional outcomes will be measured during the trial in the same manner as previously designed, using both the ADCS-iADL and the FAQ (Functional Assessment Questionnaire). These two functional outcomes will now be considered key secondary endpoints for the EXPEDITION3 study.