Alzheimer DiseaseNCT03810794
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease
A study testing Acupuncture and Donepezil in people with Alzheimer Disease and Cognitive Impairment, run by Jian Pei,MD at 3 sites in China.
Trial summary
The objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- What is being tested?
- Acupuncture and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2019to 30 Dec 2026
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 50-85 years
- the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
- cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
- magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
- the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
- voluntarily joining this study with informed consents
Who cannot join
- cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression))
- a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
- aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
- anticoagulant treatments such as warfarin or heparin
- use of pacemakers or receiving acupuncture in the past 2 weeks
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Jian Pei, Doctor, 00862164385700 ext. 3534, jianpei99@hotmail.com
- Recruiting
Shanghai Mental Center, Shanghai Jiaotong University of Medicial School
Shanghai, Shanghai Municipality, 200032
Tao Wang, Doctor, 00862163846590
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Houguang Zhou, Doctor
About this study
Official title: Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
The objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale. In this 12-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with Donepezil, a total of 180 patients with Alzheimer's disease will be recruited. The patients will be randomly assigned to acupuncture combined with Donepezil (n =90) or Donepezil treatment (n =90). (36 sessions, 3 sessions a week). Changes in the cognition over time measured using ADAS-cog is the primary outcome. MMSE, ADCS-ADL and QOL-AD are the secondary outcomes. The study will be conducted at LongHua Hospital Shanghai University of Traditional Chinese Medicine, Huashan Hospital Fudan University, and Mental Health Center Shanghai Jiao Tong University School of Medicine.
Read the detailed description
Objective: To evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale.
Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are 3 sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically. Participants in the control group will take donepezil only. A follow-up will be conducted 24 weeks after the treatment. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12. The secondary outcomes contains The change from baseline in MMSE score, ADCS-ADL score, QOL-AD score measured at weeks 12, 24 and 36.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Being tested
- Acupuncture, Donepezil
- Keywords
- Acupuncture Treatment, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.
DonepezilDrug
Also called Donepezil Hydrochloride Tablets
Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Treatment Group | Experimental | Participants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks. Receives: Other: Acupuncture; Drug: Donepezil |
| Donepezil Group | Active comparator | Participants in this group will be given only donepezil for 12 weeks. Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
Measured: Baseline(week -2), treatment at week 12
Secondary outcomes (5)
Minimum Mental State Examination(MMSE)
The change from baseline in total Minimum Mental State Examination(MMSE) score should be measured at weeks 12, 24 and 36. The maximum score of the MMSE is 30. The questions in this scale include orientation to time, orientation to place, attention and calculation, recall of three words, and visual construction. The lower scores indicate higher degree of cognitive dysfunction. The score is related to degree of education. In general, the score of normal people is 27-30.
Measured: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
The change from baseline in the Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL) score should be measured at weeks 12, 24 and 36. The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living.
Measured: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Quality of Life-Alzheimer's Disease(QOL-AD)
The change from baseline in the Quality of Life-Alzheimer's Disease(QOL-AD) score should be measured at weeks 12, 24 and 36. The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life.
Measured: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
fractional amplitude of low frequency fluctuation (fALFF)
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequency range
Measured: Baseline(week -2), Treatment at week 12
functional connectivity (FC)
FC aquired by fMRI technique measures the functional connectivity of specific brain regions to the whole brain
Measured: Baseline(week -2), Treatment at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Pei,MD
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Huashan Hospital
- Responsible party
- Sponsor-investigator, Jian Pei,MD, Shanghai University of Traditional Chinese Medicine
- Investigators
- Jian Pei, Doctor, Study chair, Longhua HospitalHouguang Zhou, Doctor, Study director, Huashan HospitalTao Wang, Doctor, Study director, Mental Health Center Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810794
- Sponsor's protocol ID
- 18401970500
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2019
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fu QH, Pei J, Zhou HG, Wang T, Zhan YJ, Tao L, Xu J, Zhou Q, Wang LY. Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial. Trials. 2022 Aug 19;23(1):695. doi: 10.1186/s13063-022-06532-1.
PubMed 35986297Zhan Y, Fu Q, Pei J, Fan M, Yu Q, Guo M, Zhou H, Wang T, Wang L, Chen Y. Modulation of Brain Activity and Functional Connectivity by Acupuncture Combined With Donepezil on Mild-to-Moderate Alzheimer's Disease: A Neuroimaging Pilot Study. Front Neurol. 2022 Jul 11;13:912923. doi: 10.3389/fneur.2022.912923. eCollection 2022.
PubMed 35899271
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease: Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03810794
- Acronym / sponsor ID
- 18401970500
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Keywords
- Acupuncture Treatment, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jian Pei,MDUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Huashan Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jan 2019 (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 objective of this proposed study is to evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale. In this 12-week, assessor-blind, a Multi-center randomized, controlled study of acupuncture as additional treatment with Donepezil, a total of 180 patients with Alzheimer's disease will be recruited. The patients will be randomly assigned to acupuncture combined with Donepezil (n =90) or Donepezil treatment (n =90). (36 sessions, 3 sessions a week). Changes in the cognition over time measured using ADAS-cog is the primary outcome. MMSE, ADCS-ADL and QOL-AD are the secondary outcomes. The study will be conducted at LongHua Hospital Shanghai University of Traditional Chinese Medicine, Huashan Hospital Fudan University, and Mental Health Center Shanghai Jiao Tong University School of Medicine.
Detailed description
Objective: To evaluate the effect and safety of acupuncture combined therapy on cognitive function, daily living ability and quality of life of Alzheimer's disease by using the international dementia certification scale.
Methods/design: A total of 180 participants with mild to moderate Alzheimer's disease will be randomly assigned to either an acupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the acupuncture combined with donepezil group will receive acupuncture treatment in combination with donepezil for 12 weeks and at same time taking donepezil. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are 3 sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically. Participants in the control group will take donepezil only. A follow-up will be conducted 24 weeks after the treatment. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at week 12. The secondary outcomes contains The change from baseline in MMSE score, ADCS-ADL score, QOL-AD score measured at weeks 12, 24 and 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Treatment Group | Experimental | Other: Acupuncture, Drug: DonepezilParticipants in this group will be given acupuncture treatment in combination with donepezil for 12 weeks. |
| Donepezil Group | Active comparator | Drug: DonepezilParticipants in this group will be given only donepezil for 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged between 50-85 years
- the diagnostic criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
- cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
- magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
- the Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
Key exclusion criteria (5 listed)
- cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression))
- a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
- aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
- anticoagulant treatments such as warfarin or heparin
- use of pacemakers or receiving acupuncture in the past 2 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 |
|---|---|---|
| AcupunctureThe main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total. | Other | Acupuncture Treatment Group |
| DonepezilAlso: Donepezil Hydrochloride TabletsDonepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically. | Drug | Acupuncture Treatment Group, Donepezil Group |
Primary outcome
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog)
Time frame: Baseline(week -2), treatment at week 12
The primary outcome are the change and effective rate from baseline in the Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) score measured at week 12. The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction.
5 secondary outcomes
Minimum Mental State Examination(MMSE)
Time frame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Alzheimer's Disease Cooperative Study-Activity of Daily Living(ADCS-ADL)
Time frame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
Quality of Life-Alzheimer's Disease(QOL-AD)
Time frame: Baseline(week -2), Treatment at week 12, Follow-up at weeks 12 and 24.
fractional amplitude of low frequency fluctuation (fALFF)
Time frame: Baseline(week -2), Treatment at week 12
functional connectivity (FC)
Time frame: Baseline(week -2), Treatment at week 12
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 6 Jan 2026.
- Derived from this study: PubMed 35986297Fu QH, Pei J, Zhou HG, Wang T, Zhan YJ, Tao L, Xu J, Zhou Q, Wang LY. Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial. Trials. 2022 Aug 19;23(1):695. doi: 10.1186/s13063-022-06532-1.
- Derived from this study: PubMed 35899271Zhan Y, Fu Q, Pei J, Fan M, Yu Q, Guo M, Zhou H, Wang T, Wang L, Chen Y. Modulation of Brain Activity and Functional Connectivity by Acupuncture Combined With Donepezil on Mild-to-Moderate Alzheimer's Disease: A Neuroimaging Pilot Study. Front Neurol. 2022 Jul 11;13:912923. doi: 10.3389/fneur.2022.912923. eCollection 2022.
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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.
Jian Pei, Doctor study chair
Longhua Hospital
Houguang Zhou, Doctor study director
Huashan Hospital
Tao Wang, Doctor study director
Mental Health Center Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Donepezil in people with Alzheimer Disease and Cognitive Impairment, run by Jian Pei,MD at 3 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 5 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Jian Pei, Doctor (00862164385700 ext. 3534, jianpei99@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-cognition(ADAS-cog) (time frame: Baseline(week -2), treatment at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810794, which also lists 2 linked publications.
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 6 Jan 2026.