Efficacy Of Bacopa Monnieri (Brahmi) And Donepezil In Alzheimer's Disease And Mild Cognitive Impairment: A Randomized Double-Blind Parallel Phase 2b Study

Effect None
Trial Design Randomized trial
Trial Length 6+ Months
Number of Subjects 34
Sex Both Genders
Notes for this study:
In a 52-week randomized, double-blind comparator trial, 34 participants with Alzheimer's disease and mild cognitive impairment took 300 mg of Bacopa extract or 10 mg of donepezil.

The primary outcome was the difference in change in Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) and postgraduate institute (PGI) memory scale. The sample size of 48 was calculated to be sufficient, but the number randomized was only 34. 21 remained in the trial for longer than 12 months, though there was an intention to treat analysis for all of them.

There wasn't a statistically significant difference for the ADAS-Cog survey, but after 12 months (but not before), there was less progression of Alzheimer's on the PGI memory scale in the donepezil group. Quality of life and other tests didn't show a statistically significant difference.

Preregistered: CTRI/2018/04/013388