Acupuncture for amnestic mild cognitive impairment (aMCI): study protocol for a pilot multicenter, randomized, parallel controlled trial

Abstract

Background: Patients with amnesic mild cognitive impairment (aMCI) are more likely to develop Alzheimer's disease (AD) than corresponding age normal population. Because AD is irreversible, early intervention for aMCI patients seems important and urgent. We have designed a pilot multicenter, randomized, parallel controlled trial to assess the efficacy and safety of acupuncture on aMCI, and explore the feasibility of acupuncture in the treatment of aMCI, so as to provide a reference for large-sample clinical trials in the next stage. Method: We designed a pilot multicenter, randomized, parallel controlled trial. This trial aims to test the feasibility of carrying out a large-sample clinical trial. In this trial, 50 eligible patients with aMCI will be included and allocated to acupuncture group (n = 25) or sham acupuncture group (n = 25) at random. Subjects will accept treatment 2 times a week for 12 weeks continuously, with a total of 24 treatment sessions. We will select six acupoints (GV20, GV14, bilateral BL18 , bilateral BL23). For the clinical outcomes, the primary outcome is Montreal cognitive assessment (MoCA), which will be assessed from baseline to the end of this trial. And the secondary outcomes are Mini-mental State Examination (MMSE), Delayed Story Recall (DSR), Clinical Dementia Rating scale (CDR), Global Deterioration Scale (GDS), Activity of Daily Life (ADL), Alzheimer's Disease Assessment Scale-Cognitive Section (ADAS-cog), brain Magnetic Resonance Imaging (MRI) , brain functional Magnetic Resonance Imaging (fMRI) and Event-related potential (ERP) P300, which will be assessed before and after treatment. In addition, we will asses the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. We will evaluate neuropsychological assessment scale (MoCA, MMSE, ADAS-cog) at 3 months and 6months after treatment. Discussion: This pilot trial aims to explore the feasibility of the trial, and verify essential information of its efficacy and safety. This pilot study will provide a preliminary basis for carrying out a larger clinical trial of acupuncture on aMCI in near future. Trial registration: Chinese Clinical Trial Registry , ChiCTR1900021557. Registered on 27 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35460. Keywords: amnestic Mild Cognitive Impairment , Acupuncture, Clinical trial

Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study

“…Moreover, body acupuncture will not be adopted. MCI is a neurodegenerative (12,13,15,(32)(33)(34). Sham acupuncture has been used in clinical studies on acupuncture to exclude the placebo effects.…”

“…As Rehacom provides standard tasks with immediate feedback, it is useful for the treatment of MCI and clinical trials (23). Fourth, the primary efficacy outcome was changed from ADAS-K-cog to the MoCA-K. MoCA has been used as the primary outcome in recent studies exploring the effects of acupuncture on MCI (16,32,34,39). In addition, MoCA has also been used to evaluate early cognitive decline and cognitive reserve (CR).…”

“…that progresses slowly; therefore, the treatment duration was changed from 8 weeks to 12 weeks to achieve sufficient therapeutic effects based on the findings of previous studies(21,(32)(33)(34). Third, the interventions of the test and control groups were changed from EA combined with CCR and CCR to EA and CCR, respectively, to explore the effects of EA on MCI rather than add-on effects.…”

Effect of summer acupoint application treatment (SAAT) on gut microbiota in healthy Asian adults: A randomized controlled trial

“…[31] Until now, few studies have investigated the effects of SAAT on redressing the disturbance of intestinal microbiota. [32] For these reasons, we designed a randomized controlled study to explore the potential biological effects of SAAT compared to placebo on the composition of fecal microbiota in healthy adults as assessed by 16S ribosomal deoxyribonucleic acid (16S rDNA) sequencing.…”