Arendash Gary, Abulaban Haitham, Steen Susan, Andel Ross, Wang Yanhong, Bai Yun, Baranowski Rob, McGarity Jon, Scritsmier Lyle, Lin Xiaoyang, Shen Ning, Aljassabi Ali, Li Yitong, Cao Chuanhai
NeuroEM Therapeutics, Inc., 13231 N. 14th Place, Phoenix, AZ 85022, USA.
Axiom Clinical Research of Florida, 2919 W. Swann Ave, Tampa, FL 33609, USA.
Medicines (Basel). 2022 Aug 3;9(8):42. doi: 10.3390/medicines9080042.
There is currently no therapeutic that can stop or reverse the progressive memory impairment of Alzheimer's disease (AD). However, we recently published that 2 months of daily, in-home transcranial electromagnetic treatment (TEMT) reversed the cognitive impairment in eight mild/moderate AD subjects. These cognitive enhancements were accompanied by predicted changes in AD markers within both the blood and cerebrospinal fluid (CSF). In view of these encouraging findings, the initial clinical study was extended twice to encompass a period of 2½ years. The present study reports on the resulting long-term safety, cognitive assessments, and AD marker evaluations from the five subjects who received long-term treatment. TEMT administration was completely safe over the 2½-year period, with no deleterious side effects. In six cognitive/functional tasks (including the ADAS-cog13, Rey AVLT, MMSE, and ADL), no decline in any measure occurred over this 2½-year period. Long-term TEMT induced reductions in the CSF levels of C-reactive protein, p-tau217, Aβ1-40, and Aβ1-42 while modulating CSF oligomeric Aβ levels. In the plasma, long-term TEMT modulated/rebalanced levels of both p-tau217 and total tau. Although only a limited number of AD patients were involved in this study, the results suggest that TEMT can stop the cognitive decline of AD over a period of at least 2½ years and can do so with no safety issues.
目前尚无能够阻止或逆转阿尔茨海默病(AD)进行性记忆损害的治疗方法。然而,我们最近发表的研究表明,为期两个月的每日居家经颅电磁治疗(TEMT)使8名轻度/中度AD患者的认知障碍得到了逆转。这些认知功能的改善伴随着血液和脑脊液(CSF)中AD标志物的预期变化。鉴于这些令人鼓舞的发现,最初的临床研究两次延长至2年半。本研究报告了接受长期治疗的5名患者的长期安全性、认知评估和AD标志物评估结果。在2年半的时间里,TEMT治疗完全安全,没有有害副作用。在六项认知/功能任务(包括ADAS-cog13、Rey听觉词语学习测验、简易精神状态检查表和日常生活能力量表)中,在这2年半的时间里,各项指标均未下降。长期TEMT可降低脑脊液中C反应蛋白、磷酸化tau蛋白217、淀粉样蛋白β1-40和淀粉样蛋白β1-42的水平,同时调节脑脊液中寡聚淀粉样蛋白β的水平。在血浆中,长期TEMT可调节/平衡磷酸化tau蛋白217和总tau蛋白的水平。尽管本研究仅涉及有限数量的AD患者,但结果表明,TEMT可在至少2年半的时间内阻止AD患者的认知衰退,且不存在安全性问题。