Lilly changes endpoint in key phase 3 Alzheimer's trial
Eli Lilly has said it has modified the endpoint in a closely-watched phase 3 trial of solanezumab in people with mild Alzheimer's, due to advances in understanding of the disease's progression.
Lilly said the original design of EXPEDITION3 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.
But it has now decided to amend the trial to include a single primary endpoint of cognition as emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline, particularly in the early stages of the disease.
Functional outcomes will be measured in the same manner as previously designed, using the ADCS-iADL and a questionnaire – but these to outcomes will become secondary endpoints.
Regulators around the world still expect cognition and function co-primary endpoints, but Lilly said it has written to them to explain the changes to the endpoint.
The changes will not affect how the trial is conducted, the company pointed out.
The last patient visit in the trial is expected in October and top-line results will be reported after completion of database lock and analysis.
EXPEDITION3 is the first phase 3 trial to evaluate only people with mild Alzheimer's dementia.
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