Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 224
- Locations
- 7
- Primary Endpoint
- Cohen Mansfield Agitation Inventory (CMAI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Cohen Mansfield Agitation Inventory (CMAI)
Time Frame: CMAI will be evaluated after the final treatment at week 8
CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior.
Secondary Outcomes
- Cohen Mansfield Agitation Inventory (CMAI)(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)(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)(The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.)
- Neuropsychiatric Inventory (NPI)(NPI will be completed before treatment and at week 8 of treatment.)
- Mini-mental State Examination (MMSE)(MMSE will be completed before treatment and at week 8 of treatment.)
- Alzheimer disease assessment scale cognition (ADAS-Cog)(ADAS-Cog scale will be completed before treatment and at week 8 of treatment.)
- Activities of daily living (ADL)(ADL scale will be completed before treatment and at week 8 of treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(PSQI will be completed before treatment and at week 8 of treatment.)
- Zarit Burden Interview(ZBI)(ZBI will be completed before treatment and at week 8 of treatment.)
Investigators
Bao-Hui Jia
Director of rehabilitation Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences