Abstract
BACKGROUND: Amnesic mild cognitive impairment (aMCI) is the main subtype of mild cognitive impairment (MCI) and has the highest risk of conversion to Alzheimer's disease (AD) among all MCI subtypes. Episodic memory impairment is the early cognitive impairment of aMCI, which has become an important target for AD prevention. Previous clinical evidence has shown that acupuncture can improve the cognitive ability of MCI patients. This experiment aimed to observe the efficacy and neural mechanism of TiaoshenYizhi acupuncture on the episodic memory of patients with aMCI. METHODS: In this multicenter, parallel-group, double-blind, randomized controlled trial, 360 aMCI participants will be recruited from six subcenters and randomly assigned to the acupuncture group, sham acupuncture group, and control group. The acupuncture group will receive TiaoshenYizhi (TSYZ) acupuncture, the sham acupuncture group will use streitberger sham acupuncture, and the control group will only receive free health education. Participants in the two acupuncture groups will receive real acupuncture treatment or placebo acupuncture three times per week, 24 sessions over 8 consecutive weeks. The primary outcome will be global cognitive ability. Secondary outcomes will be a specific cognitive domain, including episodic memory and execution ability, electroencephalogram, and functional magnetic resonance imaging data. Outcomes will be measured at baseline and the fourth and eighth weeks after randomization. Repeated measurement analysis of variance and a mixed linear model will be used to observe the intervention effect. DISCUSSION: The protocol will give a detailed procedure to the multicenter clinical trial to further evaluate the efficacy and neural mechanism of TiaoshenYizhi acupuncture on episodic memory in patients with aMCI. From this research, we expect to provide clinical evidence for early aMCI management. TRIAL REGISTRATION: http://www.chictr.org.cn/edit.aspx?pid=142612&htm=4 , identifier: ChiCTR2100054009.