Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase
Not applicable
Started
2024-07-20
Last updated
2024-07-11
Condition(s) studied
Agitation Associated With Alzheimer's DementiaAlzheimer's Dementia
Investigational drug(s) / intervention(s)
Electroacupuncture groupMicro-acupuncture group
Electroacupuncture group: Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
Micro-acupuncture group: After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Cohen Mansfield Agitation Inventory (CMAI) — CMAI will be evaluated after the final treatment at week 8 CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior.
Trial sites (7)
Facility
City
Region
Status
Beijing United Family Rehabilitation Hospital
Beijing
Beijing Municipality
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing
Beijing Municipality
Xuanwu Hospital of Capital Medical University
Beijing
Beijing Municipality
Beijing Geriatric Hospital
Beijing
Beijing Municipality
Fujian University of Traditional Chinese Medicine
Fuzhou
Fujian
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin
Heilongjiang
More Guang'anmen Hospital of China Academy of Chinese Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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