Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease

Официальное название

Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease

Обзор

The purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with Alzheimer's disease (AD). Meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.

Подробное описание

This is a multicenter, parallel-group, patient-blinded and outcome-assessor-blinded randomized controlled trial consisting of two stages: a 8-week treatment period followed by a 8-week follow-up period. The study aims to assess therapeutic efficacy and safety of electroacupuncture for agitated symptoms of AD. Approximately 224 AD patients with symptoms of agitation will be randomly assigned to the electroacupuncture group or micro-electroacupuncture group. 50 patients in each of the two groups will be selected to complete rs-fMRI scans before the initial treatment and after the last treatment in order to investigate the central mechanism underlying the effects of electroacupuncture treatment on functional activity in patients with AD patients with symptoms of agitation.

Вмешательства

• Другое Electroacupuncture group
  Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
• Другое Micro-acupuncture group
  After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.

Первичные конечные точки

• Cohen Mansfield Agitation Inventory (CMAI) [Срок оценки: CMAI will be evaluated after the final treatment at week 8]

Вторичные конечные точки (9)

• Cohen Mansfield Agitation Inventory (CMAI) [Срок оценки: The CMAI will be evaluated at week 4 of treatment and at week 4 and week 8 of follow-up]
• Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change(mADCS-CGIC) [Срок оценки: The mADCS-CGIC assessment will be completed before treatment and at week 8 of treatment.]
• the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) [Срок оценки: The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.]
• Neuropsychiatric Inventory (NPI) [Срок оценки: NPI will be completed before treatment and at week 8 of treatment.]
• Mini-mental State Examination (MMSE) [Срок оценки: MMSE will be completed before treatment and at week 8 of treatment.]
• Alzheimer disease assessment scale cognition (ADAS-Cog) [Срок оценки: ADAS-Cog scale will be completed before treatment and at week 8 of treatment.]
• Activities of daily living (ADL) [Срок оценки: ADL scale will be completed before treatment and at week 8 of treatment.]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: PSQI will be completed before treatment and at week 8 of treatment.]
• Zarit Burden Interview(ZBI) [Срок оценки: ZBI will be completed before treatment and at week 8 of treatment.]

Критерии участия

Критерии включения

• Meet the revised draft diagnostic criteria for Alzheimer's disease published by the Alzheimer's Association in 2023
• Meet the 2023 IPA definition of agitated symptoms of cognitive impairment
• Cohen Mansfield Agitation Inventory (CMAI)≥45 points
• Have been on stable anti-AD medication (cholinesterase inhibitors, etc.) for more than 1 month
• If taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization
• Subject and legal guardian and caregiver sign informed consent.

Критерии исключения

• There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
• Received electroacupuncture treatment in the past 2 weeks
• At the time of the screening, participants are participating in other clinical trials or planned to participate in other clinical trials in the next 17 weeks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Beijing United Family Rehabilitation Hospital — Пекин
• China-Japan Friendship Hospital — Пекин
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Пекин
• Xuanwu Hospital of Capital Medical University — Пекин
• Beijing Geriatric Hospital — Пекин
• Fujian University of Traditional Chinese Medicine — Фучжоу
• The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine — Харбин

Идентификаторы

NCT: NCT06495957 · 2024-075-KY-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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