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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electroacupuncture treatment

    Other intervention

    Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Affective symptom group1 intervention
Group B: Psychotic symptom group1 intervention
Group C: Hyperactivity symptom group1 intervention
Group D: Euphoric symptom group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
NPI will be performed before treatment and every month after treatment for up to 24 months
2

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.

Time frame
The ADCS-CGIC will be performed before treatment and every 2 month after treatment for up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: