A Randomized Control pilot study to test the Anti Alzheimeric efficacy of a combination of Brahmi Nei and Mild Physical Activity

The study aims to investigate the anti-Alzheimeric efficacy of Brahmi Nei along with mild physical activity in comparison with Donepezil. Earlier,  study on rodent model of Alzheimer’s disease carried out by our group showed that the therapeutic efficacy of Brahmi Nei coupled with an enriched environment reduced tau phosphorylation, plaque accumulation, and enhanced working memory, long-term memory mitochondrial bioenergetics (https://doi.org/10.1016/j.compbiomed.2021.104999, https://doi.org/10.1002/alz.064942, https://doi.org/10.1016/j.neuint.2020.104890). Based on the promising results from the pre-clinical studies, further confirmation of the therapeutic efficacy of the combination of Brahmi Nei and physical activity for effective treatment of Alzheimer’s disease is proposed to be carried out through a pilot clinical study. The therapeutic efficiency of the combination will be compared with conventional treatment using donepezil. The primary outcome will be assessed through MMSE, CDR, MOCA and 18FDG-PET data of each participant at the beginning and the end of the study. Based on the outcomes from the pilot study, phase 2 clinical trials will be initiated so that the therapeutic benefits of this combination could be effectively used in a clinical setting to benefit affected individuals. Further, the information from the donepezil arm will provide some insights as a standard arm for comparison with data obtained from cohorts treated with Brahmi Nei individually and in combination with physical and cognitive tasks.