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For either dosage arm, there were no significant differences in any of the co--primary endpoints, which included a reduction in cognitive dedine on the Alzheimer's Disease Assessment Scale-cognitive domain (ADAS-cog), the Clinical Dementia Rating Scale sum of boxes (CDR-SOB), or in the secondary endpoint of change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scores (ADCS-ADL).
The three primary endpoints of the Phase 2 study were changes in the Alzheimer's Disease Cooperative Study -- Activities of Daily Living inventory (ADCS-ADL), Clinical Dementia Rating -- Sum of Boxes (CDR-sb), and the Alzheimer's Disease Assessment Scale -- Cognitive function subscale (ADAS-cog).
Response was measured by scores on the Clinician's Interview-Based Impression of Change Plus Caregiver Input and the AD Cooperative Study Activities of Daily Living Inventory modified for severe dementia.