Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease

July 25, 2024 updated by: Bao-Hui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease

This study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate Alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To establish a prospective case registration research platform aimed at treating mild to moderate Alzheimer's disease patients presenting with behavioral and psychological symptoms. This platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (NPI) and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Scale (ADAS-CGIC), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in Alzheimer's disease patients. Furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.

Study Type

Observational

Enrollment (Estimated)

1000

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:

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

Sampling Method

Non-Probability Sample

Study Population

Alzheimer's disease patients with behavioral and psycological symptoms, such as apathy, depression, anxiety, delusions, hallucinations, irritability, etc.

Description

Inclusion Criteria:

  1. Meet the diagnostic criteria for AD in the NIA-AA standard;
  2. Clinical dementia rating scale ≤2 points;
  3. Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
  4. Sign informed consent.

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Affective symptom group
A group of Alzheimer's patients showing emotional symptoms such as anxiety, depression, apathy, etc.
Other: Electroacupuncture treatment
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
Psychotic symptom group
A group of Alzheimer's patients showing psychotic symptoms such as delusions, hallucinations, etc.
Other: Electroacupuncture treatment
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
Hyperactivity symptom group
A group of Alzheimer's patients showing hyperactivity symptoms such as irritability, aggression, aberrant motor behaviour, etc.
Other: Electroacupuncture treatment
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
Euphoric symptom group
A group of Alzheimer's patients showing euphpric symptoms.
Other: Electroacupuncture treatment
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory (NPI)
Time Frame: NPI will be performed before treatment and every month after treatment for up to 24 months
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 performed before treatment and every month after treatment for up to 24 months
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Time Frame: The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
ADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient symptoms on the ADCS-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 ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months

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 30, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-076-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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