Lower performance on the ADAS-cog/MCI test (HR 1.08 per point increase; 95% CI 1.06-1.10) and Delayed recall test (HR 0.76 per point increase; 95% CI 0.68-0.85), as well as higher MTA scores on MRI (HR 1.33 per point increase; 95% CI 1.00-1.77) were independent predictors of progression to dementia in a step-wise Cox proportional-hazards model with age and gender forced into the model.
The classic version of the Alzheimer's Disease Assessment Scale-Cognition subscale (ADAS-Cog) is generally seen as the current gold standard primary outcome measure of cognitive symptom progression in dementia clinical trials.
The data on rating scales for dementia such as Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Severe Impairment Battery were extracted from eight previous Japanese Phase II and III studies.
There were no significant differences for efficacy endpoints (AD Assessment Scale-cognitive subscale [ADAS-Cog], Disability Assessment for Dementia [DAD] and MMSE scores) between the bapi/bapi and placebo/bapi groups.