INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) presented detailed results of its phase 3 EXPEDITION3 trial at the 9th Clinical Trials on Alzheimer's Disease or CTAD meeting.
As previously disclosed, solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a study of solanezumab initiated in people with mild dementia due to Alzheimer's disease or AD, and Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to AD.
While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small.
Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo. This finding represented an 11 percent reduction in decline (p=.095), as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14) subscale. The ADAS-Cog14 measures a person's cognitive functions, including memory, attention and language abilities.
As the primary endpoint was not met in this study, the p-values for the efficacy secondary statistical analyses were not adjusted for multiple comparisons.
Patients treated with solanezumab had a 13 percent slowing of cognitive decline (p=0.014) compared to patients treated with placebo as measured by the Mini-Mental State Examination or MMSE.
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale showed a 15 percent slowing in decline (p=0.004) between patients treated with solanezumab and patients treated with placebo.
Patients treated with solanezumab had a slowing of decline in complex activities of daily living compared to patients treated with placebo. This finding represented a 14 percent slowing of decline (p=.019) as measured by the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL).
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