Electroacupuncture Treatment of Behavioral and Psycological Symptoms in Patients With 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.

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Key information

Conditions

BPSD (Behavioral and Psycological Symptoms of Dementia) Alzheimer Disease Alzheimer's Dementia Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Geriatric Hospital, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

1.There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal

Treatment and study plan

Electroacupuncture treatment

Other

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

Primary outcomes

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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Baohui B Jia

CONTACT

[email protected]

010-88001454

Ran Li

CONTACT

[email protected]

18801094908

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Prospective Registry of Electroacupuncture Treatment for Patients With Different Behavioral and Psycological Symptoms of Alzheimer's Disease

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jul 26, 2024
Registry last updated: Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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