Endpoints and assessments
The primary endpoint of efficacy was the change from baseline in Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-CogSecondary endpoints included change from baseline in the Alzheimer’s Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) score and the Clinician’s Interview-Based Impression of Change (CIBIC+) score after 12 weeks of treatment. The ADCS-ADL is a 23-item rating scale [A further endpoint was the change from baseline in the Neuropsychiatric Inventory (NPI) score after 12 weeks of treatment. NPI is a neuropsychiatric scale that consists of 10 domains that are rated for both frequency (range: 1–4) and severity (range: 1–3). A composite score for each domain is then calculated (frequency × severity), which ranges from 1–12.