Clinical trial NCT06495957: Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease
Official title: Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Agitation Associated With Alzheimer's Dementia
Alzheimer's Dementia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. There are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
2. Received electroacupuncture treatment in the past 2 weeks
3. 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.

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