Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease

Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease

The purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with Alzheimer's disease (AD). Meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.

This is a multicenter, parallel-group, patient-blinded and outcome-assessor-blinded randomized controlled trial consisting of two stages: a 8-week treatment period followed by a 8-week follow-up period. The study aims to assess therapeutic efficacy and safety of electroacupuncture for agitated symptoms of AD. Approximately 224 AD patients with symptoms of agitation will be randomly assigned to the electroacupuncture group or micro-electroacupuncture group. 50 patients in each of the two groups will be selected to complete rs-fMRI scans before the initial treatment and after the last treatment in order to investigate the central mechanism underlying the effects of electroacupuncture treatment on functional activity in patients with AD patients with symptoms of agitation.

Inclusion Criteria:

1. Meet the revised draft diagnostic criteria for Alzheimer's disease published by the Alzheimer's Association in 2023
2. Meet the 2023 IPA definition of agitated symptoms of cognitive impairment
3. Cohen Mansfield Agitation Inventory (CMAI)≥45 points
4. Have been on stable anti-AD medication (cholinesterase inhibitors, etc.) for more than 1 month
5. If taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization
6. Subject and legal guardian and caregiver sign informed consent.

Exclusion Criteria:

1. There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
2. Received electroacupuncture treatment in the past 2 weeks
3. At the time of the screening, participants are participating in other clinical trials or planned to participate in other clinical trials in the next 17 weeks.