Status:
NOT_YET_RECRUITING
Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Agitation Associated With Alzheimer's Dementia
Alzheimer's Dementia
Eligibility:
All Genders
Phase:
NA
Brief 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 br...
Detailed Description
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 perio...
Eligibility Criteria
Inclusion
- 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
- If taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization
- Subject and legal guardian and caregiver sign informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06495957
Start Date
July 20 2024
End Date
October 31 2027
Last Update
July 11 2024
Active Locations (7)
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1
Beijing United Family Rehabilitation Hospital
Beijing, Beijing Municipality, China, 100015
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053
4
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100053