Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroacupuncture group, Micro-acupuncture group.
- Who it may be relevant to
- Registry conditions: Agitation Associated With Alzheimer's Dementia, Alzheimer's Dementia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
Overview
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.
Interventions
- Other Electroacupuncture group
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. - Other Micro-acupuncture group
After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.
Primary outcome measures
- Cohen Mansfield Agitation Inventory (CMAI) [Time frame: CMAI will be evaluated after the final treatment at week 8]
Secondary outcome measures (9)
- Cohen Mansfield Agitation Inventory (CMAI) [Time frame: 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) [Time frame: 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) [Time frame: The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.]
- Neuropsychiatric Inventory (NPI) [Time frame: NPI will be completed before treatment and at week 8 of treatment.]
- Mini-mental State Examination (MMSE) [Time frame: MMSE will be completed before treatment and at week 8 of treatment.]
- Alzheimer disease assessment scale cognition (ADAS-Cog) [Time frame: ADAS-Cog scale will be completed before treatment and at week 8 of treatment.]
- Activities of daily living (ADL) [Time frame: ADL scale will be completed before treatment and at week 8 of treatment.]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: PSQI will be completed before treatment and at week 8 of treatment.]
- Zarit Burden Interview(ZBI) [Time frame: ZBI will be completed before treatment and at week 8 of treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Beijing United Family Rehabilitation Hospital — Beijing
- China-Japan Friendship Hospital — Beijing
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences — Beijing
- Xuanwu Hospital of Capital Medical University — Beijing
- Beijing Geriatric Hospital — Beijing
- Fujian University of Traditional Chinese Medicine — Fuzhou
- The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine — Harbin
Identifiers
NCT: NCT06495957 · 2024-075-KY-01