Pyo, Geunyeong Elble, Rodger J Ala, Thomas Markwell, Stephen J The characteristics of patients with uncertain/mild cognitive impairment on the Alzheimer disease assessment scale- cognitive subscale. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.
The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect.
#Cogs 3 boyle trial#
The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. Using item response theory, we developed a new scoring methodology ( ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Verma, Nishant Beretvas, S Natasha Pascual, Belen Masdeu, Joseph C Markey, Mia KĪs currently used, the Alzheimer's Disease Assessment Scale- Cognitive subscale ( ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale- Cognitive subscale ( ADAS-Cog) in clinical trials.
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