Agitation Associated With Alzheimer's DementiaNCT06495957
Electroacupuncture for the Treatment of Agitated Symptoms of Alzheimer's Disease
A study testing Electroacupuncture group and Micro-acupuncture group in people with Agitation Associated With Alzheimer's Dementia and Alzheimer's Dementia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Agitation Associated With Alzheimer's Dementia, Alzheimer's Dementia
- What is being tested?
- Electroacupuncture group and Micro-acupuncture group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 7 sitesChina
- Study dates
- 20 Jul 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Beijing United Family Rehabilitation Hospital
Beijing, Beijing Municipality, 100015
Dongmei Li, 13717850887, 13717850887@139.com
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Rongxing Shi, 18610153099, 2243111436@qq.com
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Ran Li, 010-88001454, lcgxliran@163.com
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
Aihong Zhou, 010-83192333, zahxwh@163.com
Beijing Geriatric Hospital
Beijing, Beijing Municipality, 100095
Jihui Lv, 13520094838, lvjihui@139.com
Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350122
Ying Xu, 0591-22861815, aaa8858@qq.com
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150001
Li Zhang
About this study
Official title: Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
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.
Read the 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.
- Being tested
- Electroacupuncture group, Micro-acupuncture group
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture groupOther
Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes.
Micro-acupuncture groupOther
After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | 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. Receives: Other: Electroacupuncture group |
| Micro-acupuncture group | Other | 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. Receives: Other: Micro-acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: CMAI will be evaluated after the final treatment at week 8
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: ZBI will be completed before treatment and at week 8 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start20 Jul 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation Associated With Alzheimer's DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bao-Hui Jia, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Baohui Jia, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495957
- Sponsor's protocol ID
- 2024-075-KY-01
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Effect and Brain Mechanism of Electroacupuncture in Treating Agitation Symptoms of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06495957
- Acronym / sponsor ID
- 2024-075-KY-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Other: Electroacupuncture groupNeedles 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. |
| Micro-acupuncture group | Other | Other: Micro-acupuncture group11 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture groupElectroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. | Other | Electroacupuncture group |
| Micro-acupuncture groupAfter acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds. | Other | Micro-acupuncture group |
Primary outcome
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baohui Jia principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture group and Micro-acupuncture group in people with Agitation Associated With Alzheimer's Dementia and Alzheimer's Dementia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baohui Jia (010-88001454, jiabaohui2504@gamyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen Mansfield Agitation Inventory (CMAI) (time frame: CMAI will be evaluated after the final treatment at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.