Clinical trial NCT06523309: Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With Alzheimer's Disease
Official title: Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia)
Alzheimer's Dementia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychiatric Inventory (NPI)
timeFrame: NPI will be performed before treatment and every month after treatment for up to 24 months
measure: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
timeFrame: The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing United Family Rehabilitation Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Geriatric Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian University of Traditional Chinese Medicine
state: Fujian
city: Ha'erbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Baohui Jia
role: PRINCIPAL_INVESTIGATOR
References: