PMID- 33361021 OWN - NLM STAT- MEDLINE DCOM- 20210806 LR - 20210806 IS - 1011-601X (Print) IS - 1011-601X (Linking) VI - 33 IP - 3(Special) DP - 2020 May TI - Efficacy and safety of MAO-B inhibitor versus donepezil in Chinese elderly stroke patients with Alzheimer disease: A potential therapeutic option. PG - 1349-1354 AB - This pilot study designed to evaluate the efficacy and safety of MAO-B inhibitor in comparison with Donepezil (DNP) in elderly Chinese patients with Alzheimer disease (AD). In the present clinical trial, Chinese elderly patients aged >/=65 years with a confirmed diagnosis of AD were enrolled. The patients received MAO-B inhibitor (Selegiline 5 mg) or DNP 10 mg daily (reference) for 6 months. The efficacy and safety data were collected from 120 patients (60 patients in each group) every 3 weeks until 6 months. The primary endpoints were to assess the change in cognitive score from baseline in both the treatment group. The result of the present study showed that the patients treated with MAO-B inhibitor and DNP have similar efficacy and safety profile Considering the clinical benefit, mean (SD) improvement in sign and symptoms was numerically greater in DNP-treated patients as compared to MAO-B inhibitor at endpoint visit (SIB: 12.3 (3.7) vs 11.3 (4.2); AD severity: 14.2 (3.5); CIBIS+/CIBIC: 10.2 (2.7) vs 9.4 (3.2); ADCS-ADL: 14.3 (4.2) vs 13.2 (3.4); MMSE: 14.3 (3.7) vs 12.2 (3.2), P>0.05 respectively for each comparison). However, a statistical difference in terms of clinical benefit was similar between both the treatment groups (p>0.05). Overall, both the study drugs were found comparable in relieving the symptoms of AD (severity score after end of treatment: 14.2 vs 13.4 respectively; p >0.05). This indicates that MAO-B inhibitor is a potential target for the treatment of AD in China. The results of the present study may help to design a large clinical trial to evaluate the efficacy and safety of MAO-B inhibitor in comparison with DNP in AD patients. FAU - Yang, Huaqing AU - Yang H AD - Department of Neurology, Central Hospital of Xinwen Mining Group Co., Ltd., Xintai, Shandong, China. FAU - Han, Weidong AU - Han W AD - Department of Neurology, Central Hospital of Xinwen Mining Group Co., Ltd., Xintai, Shandong, China. FAU - Li, Hui AU - Li H AD - Department of Anesthesiology, Suzhou Ninth People's Hospital, Jiangsu, China. LA - eng PT - Clinical Study PT - Comparative Study PT - Journal Article PL - Pakistan TA - Pak J Pharm Sci JT - Pakistan journal of pharmaceutical sciences JID - 9426356 RN - 0 (Cholinesterase Inhibitors) RN - 0 (Monoamine Oxidase Inhibitors) RN - 0 (Nootropic Agents) RN - 2K1V7GP655 (Selegiline) RN - 8SSC91326P (Donepezil) SB - IM MH - Age Factors MH - Aged MH - Alzheimer Disease/complications/diagnosis/*drug therapy/psychology MH - China MH - Cholinesterase Inhibitors/adverse effects/*therapeutic use MH - Cognition/*drug effects MH - Donepezil/adverse effects/*therapeutic use MH - Female MH - Humans MH - Male MH - Monoamine Oxidase Inhibitors/adverse effects/*therapeutic use MH - Nootropic Agents/adverse effects/*therapeutic use MH - Pilot Projects MH - Random Allocation MH - Selegiline/adverse effects/*therapeutic use MH - Stroke/*complications/diagnosis/psychology MH - Time Factors MH - Treatment Outcome EDAT- 2020/12/29 06:00 MHDA- 2021/08/07 06:00 CRDT- 2020/12/28 11:40 PHST- 2020/12/28 11:40 [entrez] PHST- 2020/12/29 06:00 [pubmed] PHST- 2021/08/07 06:00 [medline] PST - ppublish SO - Pak J Pharm Sci. 2020 May;33(3(Special)):1349-1354.