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

Not yet recruiting
Conditions
BPSD (Behavioral and Psycological Symptoms of Dementia)
Alzheimer's Dementia
Interventions
Other: Electroacupuncture treatment
Registration Number
NCT06523309
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Euphoric symptom groupElectroacupuncture treatmentA group of Alzheimer's patients showing euphpric symptoms.
Psychotic symptom groupElectroacupuncture treatmentA group of Alzheimer's patients showing psychotic symptoms such as delusions, hallucinations, etc.
Affective symptom groupElectroacupuncture treatmentA group of Alzheimer's patients showing emotional symptoms such as anxiety, depression, apathy, etc.
Hyperactivity symptom groupElectroacupuncture treatmentA group of Alzheimer's patients showing hyperactivity symptoms such as irritability, aggression, aberrant motor behaviour, etc.
Primary Outcome Measures
NameTimeMethod
Neuropsychiatric Inventory (NPI)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.

Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Fujian University of Traditional Chinese Medicine

🇨🇳

Fuzhou, Fujian, China

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

🇨🇳

Ha'erbin, Heilongjiang, China

Beijing United Family Rehabilitation Hospital

🇨🇳

Beijing, Beijing, China

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

🇨🇳

Beijing, Beijing, China

China-Japan Friendship Hospital

🇨🇳

Beijing, Beijing, China

Xuanwu Hospital of Capital Medical University

🇨🇳

Beijing, Beijing, China

Beijing Geriatric Hospital

🇨🇳

Beijing, Beijing, China

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