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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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