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12/30/20 7:02 PM

#291021 RE: rayovacAAA #291012

Historic placebo arms are acceptable in Azheimer's, this is a report on another drug, dated January 2017:

There were no drug-related serious AEs or clinically significant laboratory abnormalities. At 26 weeks, Alzheimer's Disease Assessment Scale Cognitive Component scores in the efficacy evaluable population improved by 0.35 ± 0.85 points over baseline (p < 0.05), an estimated 2.5 ± 0.84 points above 10 mg/day donepezil and 5.4 ± 0.84 points above historic placebo (both p < 0.05). Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001). The findings suggest that limiting donepezil AEs by co-administration of solifenacin allows the safe administration of substantially higher cholinesterase inhibitors doses that may augment cognitive and global benefits in patients with AD.



https://www.researchgate.net/publication/313127711_Donepezil_Plus_Solifenacin_CPC-201_Treatment_for_Alzheimer's_Disease