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Clinical Trial NCT06495957 for Agitation Associated With Alzheimer's Dementia, Alzheimer's Dementia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease 224

Not yet recruiting
Clinical Trial NCT06495957 is an interventional study for Agitation Associated With Alzheimer's Dementia, Alzheimer's Dementia and is currently not yet recruiting. Enrollment is planned to begin on 20 July 2024 and continue until the study accrues 224 participants. Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, this study is expected to complete by 31 October 2027. The latest data from ClinicalTrials.gov was last updated on 11 July 2024.
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 ...Show More
Official Title

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

Conditions
Agitation Associated With Alzheimer's DementiaAlzheimer's Dementia
Other Study IDs
  • 2024-075-KY-01
NCT ID Number
NCT06495957
Start Date (Actual)
2024-07-20
Last Update Posted
2024-07-11
Completion Date (Estimated)
2027-10-31
Enrollment (Estimated)
224
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalElectroacupuncture group
Needles will be inserted at 11 acupoints. Acupoints will be added electrical stimulation via a low-frequency neural regulator (electrical stimulator) respectively with a disperse-dense wave after insertion of all needles. Twenty-minute treatments will be delivered three times weekly for 8 weeks.
Electroacupuncture group
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
OtherMicro-acupuncture group
11 needles will be inserted at acupoints with 1-3 mm in depth. The acupoints will then be connected to the electrical stimulator in accordance with the electroacupuncture group. The frequency of the electroacupuncture is the same as that of the electroacupuncture group, which is briefly energized at the beginning for 30s.Twenty-minute treatments will be delivered three times weekly for 8 weeks.
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
Outcome MeasureMeasure DescriptionTime Frame
Cohen Mansfield Agitation Inventory (CMAI)
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.
CMAI will be evaluated after the final treatment at week 8
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cohen Mansfield Agitation Inventory (CMAI)
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.
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)
mADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient agitation on the mADCS-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.
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 scale is used to assess the behavioral pathology of patients with Alzheimer's disease. It contains 25 items to assess patients' symptoms and severity across multiple behavioral areas. The higher the total score of BEHAVE-AD, the more serious the behavioral pathology of the patient.
The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment.
Neuropsychiatric Inventory (NPI)
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.
NPI will be completed before treatment and at week 8 of treatment.
Mini-mental State Examination (MMSE)
The MMSE scale can comprehensively, accurately and quickly reflect the intellectual state and cognitive function defect of the subjects. The total score ranges from 0 to 30 points, and the higher the score is, the better the cognitive function is
MMSE will be completed before treatment and at week 8 of treatment.
Alzheimer disease assessment scale cognition (ADAS-Cog)
The ADAS-Cog scale is a scale commonly used to assess cognitive impairment in Alzheimer's patients on a scale ranging from 0 to 70 points, with higher scores indicating more severe cognitive impairment.
ADAS-Cog scale will be completed before treatment and at week 8 of treatment.
Activities of daily living (ADL)
The ADL consists of the Physical self-maintenance scale (PSMS) and the Instrumental Activities of daily living Scale (IADL). Higher scores indicating lower ability.
ADL scale will be completed before treatment and at week 8 of treatment.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI Scale is a standardized tool used to assess sleep quality and contains 7 sections covering the main aspects of sleep quality. Each section was scored on a scale of 0-3, and the overall score was 0-21, with higher scores indicating poorer sleep quality.
PSQI will be completed before treatment and at week 8 of treatment.
Zarit Burden Interview(ZBI)
The ZBI scale is a tool used to assess the degree of psychological and physical burden on caregivers caring for family members with cognitive impairment or chronic illness. The total score ranges from 0 to 88, with higher scores indicating higher caregiving burden.
ZBI will be completed before treatment and at week 8 of treatment.
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  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.

  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.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences logoGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Responsible Party
Bao-Hui Jia, Principal Investigator, Director of rehabilitation Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Central Contact
Contact: Baohui Jia, 010-88001454, [email protected]
Contact: Ran Li, 18801094908, [email protected]
7 Study Locations in 1 Countries

Beijing Municipality

Beijing United Family Rehabilitation Hospital, Beijing, Beijing Municipality, 100015, China
Dongmei Li, Contact, 13717850887, [email protected]
China-Japan Friendship Hospital, Beijing, Beijing Municipality, 100029, China
Rongxing Shi, Contact, 18610153099, [email protected]
Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, 100053, China
Ran Li, Contact, 010-88001454, [email protected]
Xuanwu Hospital of Capital Medical University, Beijing, Beijing Municipality, 100053, China
Aihong Zhou, Contact, 010-83192333, [email protected]
Beijing Geriatric Hospital, Beijing, Beijing Municipality, 100095, China
Jihui Lv, Contact, 13520094838, [email protected]

Fujian

Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, 350122, China
Ying Xu, Contact, 0591-22861815, [email protected]

Heilongjiang

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, 150001, China
Li Zhang, Contact