| Popis: |
Background: Dementia causes a long-term and gradual cognitive decline and there is no treatment to slow or stop the progression of dementia. Methods: Middle cerebral artery occlusion in rats was employed to investigate the effects of BAC in neural inflammation. A phase II study was conducted in Alzheimer’s disease or vascular dementia patients. BAC or matched vehicle was applied topically on the subject’s external nasal skin, scalp, and neck, twice daily, 30 grams per day for 12 weeks. Cognitive evaluation questionnaires including ADAS-Cog, ADCS-ADL, MMSE, NPI, CIBIS, and CIBIC-plus scores were performed to evaluate the efficacy. A responder analysis was conducted with stratification of different sub-groups of receiving/not receiving dementia medication or donepezil hydrochloride and type of dementia.Results: The responder analysis showed that the naïve and not using donepezil hydrochloride sub-groups in the BAC-treated group had a higher responder rate compared to using donepezil hydrochloride and any dementia medication sub-groups. The BAC group showed a higher percentage of responders than the vehicle group in the mixed dementia population.Conclusion: BAC was safe for human use. BAC improved the responder rate in naïve dementia patients regardless of dementia type and in patients not receiving donepezil hydrochloride. The bigger sample size is required to confirm the efficacy of BAC.Trial registration: NCT02886494 (First posted: September 1, 2016) |
