Recruiting soon

Electroacupuncture for Agitation in Alzheimer's Disease

Study Aim

This study aims to evaluate if electroacupuncture can help reduce agitation in people with Alzheimer's disease by using a behavior assessment scale.

What is being tested

Electroacupuncture group

+ Micro-acupuncture group

Other

Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2024

See protocol details

Summary

Principal SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

Study ContactBaohui JiaMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2024

Actual date on which the first participant was enrolled.

The study is focused on evaluating the effectiveness and safety of electroacupuncture in managing agitation symptoms in individuals with Alzheimer's Disease (AD). Agitation is a common and challenging symptom for people living with AD, and this research seeks to find better ways to address it. By exploring electroacupuncture, the study hopes to offer a new therapeutic option that could improve the quality of life for those affected by AD. The trial involves a diverse group of participants from multiple centers to ensure comprehensive and reliable results. Participants in the study will be randomly divided into two groups: one receiving electroacupuncture and the other receiving a micro-electroacupuncture treatment. The treatments will extend over an 8-week period, with an additional 8-week follow-up to assess long-term effects. To understand how electroacupuncture affects the brain, 50 patients from each group will undergo brain scans before and after the treatment period. These scans help researchers identify changes in brain activity related to the treatment. The study is designed to be patient-blinded, meaning participants will not know which treatment they are receiving, to ensure unbiased results.

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

NCT06495957

Principal SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

Study ContactBaohui JiaMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

224 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

6 inclusion criteria required to participate

Meet the revised draft diagnostic criteria for Alzheimer's disease published by the Alzheimer's Association in 2023

Meet the 2023 IPA definition of agitated symptoms of cognitive impairment

Cohen Mansfield Agitation Inventory (CMAI)≥45 points

Have been on stable anti-AD medication (cholinesterase inhibitors, etc.) for more than 1 month

Show More Criteria

3 exclusion criteria prevent from participating

There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal

Received electroacupuncture treatment in the past 2 weeks

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Needles will be inserted at 11 acupoints. Acupoints will be added electrical stimulation via a low-frequency neural regulator (electrical stimulator) respectively with a disperse-dense wave after insertion of all needles. Twenty-minute treatments will be delivered three times weekly for 8 weeks.

Group II

11 needles will be inserted at acupoints with 1-3 mm in depth. The acupoints will then be connected to the electrical stimulator in accordance with the electroacupuncture group. The frequency of the electroacupuncture is the same as that of the electroacupuncture group, which is briefly energized at the beginning for 30s.Twenty-minute treatments will be delivered three times weekly for 8 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Beijing United Family Rehabilitation Hospital

Beijing, ChinaOpen Beijing United Family Rehabilitation Hospital in Google Maps

Suspended

China-Japan Friendship Hospital

Beijing, China

Suspended

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Suspended

Xuanwu Hospital of Capital Medical University

Beijing, China

Recruiting soon7 Study Centers