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.
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.
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.
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.