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

July 3, 2024 updated by: Bao-Hui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 100053
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100095
        • Beijing Geriatric Hospital
        • Contact:
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital of Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100015
        • Beijing United Family Rehabilitation Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350122
        • Fujian University of Traditional Chinese Medicine
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150001
        • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
        • Contact:
          • Li Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture group
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.
Other: Electroacupuncture group
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
Other: Micro-acupuncture group
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.
Other: Micro-acupuncture group
After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen Mansfield Agitation Inventory (CMAI)
Time Frame: 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.
CMAI will be evaluated after the final treatment at week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen Mansfield Agitation Inventory (CMAI)
Time Frame: The CMAI will be evaluated at week 4 of treatment and at week 4 and week 8 of follow-up
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.
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)
Time Frame: The mADCS-CGIC assessment will be completed before treatment and at week 8 of treatment.
mADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient agitation on the mADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms.
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)
Time Frame: The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.
The BEHAVE-AD scale is used to assess the behavioral pathology of patients with Alzheimer's disease. It contains 25 items to assess patients' symptoms and severity across multiple behavioral areas. The higher the total score of BEHAVE-AD, the more serious the behavioral pathology of the patient.
The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.
Neuropsychiatric Inventory (NPI)
Time Frame: NPI will be completed before treatment and at week 8 of treatment.
NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is.
NPI will be completed before treatment and at week 8 of treatment.
Mini-mental State Examination (MMSE)
Time Frame: MMSE will be completed before treatment and at week 8 of treatment.
The MMSE scale can comprehensively, accurately and quickly reflect the intellectual state and cognitive function defect of the subjects. The total score ranges from 0 to 30 points, and the higher the score is, the better the cognitive function is
MMSE will be completed before treatment and at week 8 of treatment.
Alzheimer disease assessment scale cognition (ADAS-Cog)
Time Frame: ADAS-Cog scale will be completed before treatment and at week 8 of treatment.
The ADAS-Cog scale is a scale commonly used to assess cognitive impairment in Alzheimer's patients on a scale ranging from 0 to 70 points, with higher scores indicating more severe cognitive impairment.
ADAS-Cog scale will be completed before treatment and at week 8 of treatment.
Activities of daily living (ADL)
Time Frame: ADL scale will be completed before treatment and at week 8 of treatment.
The ADL consists of the Physical self-maintenance scale (PSMS) and the Instrumental Activities of daily living Scale (IADL). Higher scores indicating lower ability.
ADL scale will be completed before treatment and at week 8 of treatment.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: PSQI will be completed before treatment and at week 8 of treatment.
The PSQI Scale is a standardized tool used to assess sleep quality and contains 7 sections covering the main aspects of sleep quality. Each section was scored on a scale of 0-3, and the overall score was 0-21, with higher scores indicating poorer sleep quality.
PSQI will be completed before treatment and at week 8 of treatment.
Zarit Burden Interview(ZBI)
Time Frame: ZBI will be completed before treatment and at week 8 of treatment.
The ZBI scale is a tool used to assess the degree of psychological and physical burden on caregivers caring for family members with cognitive impairment or chronic illness. The total score ranges from 0 to 88, with higher scores indicating higher caregiving burden.
ZBI will be completed before treatment and at week 8 of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Principal Investigator: Baohui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-075-KY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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