Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease
Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease
1 other identifier
observational
1,000
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Typical duration for all trials
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 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
July 30, 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 26, 2024
July 1, 2024
3 years
July 19, 2024
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Neuropsychiatric Inventory (NPI)
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)
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
Study Arms (4)
Affective symptom group
A group of Alzheimer's patients showing emotional symptoms such as anxiety, depression, apathy, etc.
Psychotic symptom group
A group of Alzheimer's patients showing psychotic symptoms such as delusions, hallucinations, etc.
Hyperactivity symptom group
A group of Alzheimer's patients showing hyperactivity symptoms such as irritability, aggression, aberrant motor behaviour, etc.
Euphoric symptom group
A group of Alzheimer's patients showing euphpric symptoms.
Interventions
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.
Eligibility Criteria
Alzheimer's disease patients with behavioral and psycological symptoms, such as apathy, depression, anxiety, delusions, hallucinations, irritability, etc.
You may qualify if:
- Meet the diagnostic criteria for AD in the NIA-AA standard;
- Clinical dementia rating scale ≤2 points;
- Accompanied by at least one psychobehavioral symptom, NPI：frequency × degree ≥1 point;
- 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
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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of rehabilitation Medicine
Study Record Dates
First Submitted
July 19, 2024
First Posted
July 26, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
July 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share