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
1 other identifier
interventional
224
1 country
7
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 brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedStudy Start
First participant enrolled
July 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
July 11, 2024
July 1, 2024
3 years
July 3, 2024
July 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cohen Mansfield Agitation Inventory (CMAI)
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.
CMAI will be evaluated after the final treatment at week 8
Secondary Outcomes (9)
Cohen Mansfield Agitation Inventory (CMAI)
The CMAI will be evaluated at week 4 of treatment and at week 4 and week 8 of follow-up
Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change(mADCS-CGIC)
The mADCS-CGIC assessment will be completed before treatment and at week 8 of treatment.
the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)
The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.
Neuropsychiatric Inventory (NPI)
NPI will be completed before treatment and at week 8 of treatment.
Mini-mental State Examination (MMSE)
MMSE will be completed before treatment and at week 8 of treatment.
- +4 more secondary outcomes
Study Arms (2)
Electroacupuncture group
EXPERIMENTALNeedles 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.
Micro-acupuncture group
OTHER11 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.
Interventions
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Beijing United Family Rehabilitation Hospital
Beijing, Beijing Municipality, 100015, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Geriatric Hospital
Beijing, Beijing Municipality, 100095, China
Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350122, China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baohui Jia
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of rehabilitation Medicine
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 11, 2024
Study Start
July 20, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share