ALZForum on cognitive assessment

Development in the area of cognitive assessment of AD tells us that the current measures of assessment are largely inadequate.

From December 2015 conference news "In people at the earliest stages of cognitive decline, existing instruments like the ADAS-Cog are inadequate because everyone aces the test. Some trialists have turned to the CDR-sb, which detects subtle impairment and can stage disease accurately. However, some experts say CDR-sb does not measure changes finely enough to be useful as an outcome measure in trials of preclinical or early dementia (see Nov 2015 conference news). Researchers fear trials may miss a treatment effect due to the bluntness of the instrument used to measure it. To better capture decline, some groups have developed cognitive composites or functional questionnaires, which look promising in initial studies (see Feb 2013 Webinar; Jun 2014 news; Mar 2015 news). However, most of these tools remain in research use only, and have yet to receive either marketing clearance or validation as biomarkers from the FDA."

and...from year end summary -
"Regulators are following these developments closely. While the Food and Drug Administration traditionally has required that a drug sponsor demonstrate both cognitive and functional efficacy to get an AD medication approved, the agency has acknowledged that the latter is difficult to do in people who start therapy while unimpaired. The agency has indicated that it may consider a single measure instead (see Mar 2013 news). Throughout the year 2015, agency scientists met with AD scientists in both closed and public meetings, from AAIC to a year-end workshop seeking guidance for validating new measures and devices for cognitive decline (see Dec 2015 conference news)."