Alzheimer Disease 1NCT05078944
Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture
A study testing Active acupuncture and Donepezil Hydrochloride in people with Alzheimer Disease 1, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease 1
- What is being tested?
- Active acupuncture and Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
- Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score
Who cannot join
- Dementia due to other causes
- Evidence of a clinically relevant or unstable psychiatric disorder
- Has irritable bowel syndrome or inflammatory bowel disease
- Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
- Has visual or hearing disorder, defeating completion of evaluation
- Use of AD therapy (except for donepezil hydrochloride) which cannot be stopped
Show all 12Show fewer
- Use of antibiotics within 1 month prior to enrollment
- Has a history of gastrointestinal surgery (except for appendicitis and hernia surgery)
- Without a reliable caregiver who will accompany the participant during treatment and assessment, and monitor administration of the prescribed medications
- With cardiac pacemaker or metal allergy
- Once experienced electroacupuncture treatment before at any time (manual acupuncture is allowed)
- Premenopausal woman
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization
Shanghai, 200030
About this study
Official title: Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
Read the detailed description
Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI).
- Conditions
- Alzheimer Disease 1
- Being tested
- Active acupuncture, Sham acupuncture, Donepezil Hydrochloride
- Keywords
- Alzheimer's Disease, Electroacupuncture
- Medical subject headings
- Alzheimer disease type 1, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active acupunctureDevice
Acupoints: Principal: GV20, EX-HN1, GV24 and bilateral PC6, HT7, ST36, KI3, SP6. Additional: CV6 and bilateral GB39, ST40, SP10 Sterile stainless steel disposable acupuncture needles (size 0.30 × 50 mm, Hwato brand, China) are used. After sterilization, a small plastic ring will be fixed over the acupuncture point with plaster to facilitate maintenance of blinding for the participant, and then the needle will be inserted through the plaster inside the ring. The electric stimulator (SDZ-Ⅲ electroacupuncture apparatus, Hwato brand, China) is applied to GV20, GV24, bilateral PC6 and HT7, dilatational wave, 10/50 Hz and tolerable electric current. Needles placed in other acupoints will be manually stimulated by rotation every 15 minutes. Each session lasts for 45 min.
Sham acupunctureDevice
Sham acupoints: SA1 (5 cun lateral to GV5), SA2 (5 cun lateral to GV4), SA3 (1 cun lateral to BL56).
After sterilization, pragmatic placebo needles with blunt tip (size 0.30 × 50 mm, Hwato brand, China) are used. When their tips are pressed against the skin through plastic rings, participants will feel a pricking sensation. The electric stimulator is applied to bilateral SA1 and SA2 with no current output. The mental wire has been cut off with a same outlook as the electroacupuncture group. Needles placed in SA3 will be manually rotated every 15 minutes. Each session lasts for 45 min.
Donepezil HydrochlorideDrug
Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Active acupuncture + Donepezil | Experimental | Active acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride Receives: Device: Active acupuncture; Drug: Donepezil Hydrochloride |
| Sham acupuncture + Donepezil | Sham comparator | Sham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride Receives: Device: Sham acupuncture; Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 12 items (ranges from 0 to 75). Higher scores indicating greater cognitive impairment.
Measured: Week 14
Secondary outcomes (6)
Change From Baseline in Mini-Mental State Examination (MMSE)
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
Measured: Baseline, Week 7, Week 14, Week 21, Week 28
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
Measured: Baseline, Week 7, Week 14, Week 21, Week 28
Change From Baseline in Neuropsychiatric Inventory (NPI)
NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 0 to 144, with lower scores indicating fewer behavioral disturbances
Measured: Baseline, Week 7, Week 14, Week 21, Week 28
Treatment Credibility
The treatment credibility scale will be assessed by asking participants to rate their response to four questions on a 5-point scale developed by Borkovec and Nau. Total score ranges from 0 to 20; higher score indicates greater treatment credibility.
Measured: Week 1, Week 14
Incidence of Adverse Events
Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture.
Measured: Week -4 to Week 28
Change in Gut Microbiota Diversity Based on 16S rRNA Gene Sequencing Analysis
Stool samples will be processed to extract DNA, followed by 16S rRNA gene sequencing analysis using QIIME and R packages (v3.2.0).
Measured: Baseline, Week 14, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start30 Jun 2022
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease 1Studies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaopeng Ma, MD, PhD, Study chair, Shanghai Institute of Acupuncture, Moxibustion and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078944
- Sponsor's protocol ID
- ShanghaiIAMM2021052
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kong X, Han R, Fan X, Wei K, Ma Z, Yang G, Zhao Y, Yang Y, Yang Y, Hong J, Liu J, Zhang D, Ma X. Acupuncture as an adjunct therapy for mild Alzheimer's disease: A randomized clinical trial. J Alzheimers Dis. 2026 May;111(2):757-767. doi: 10.1177/13872877261435880. Epub 2026 Mar 30.
PubMed 41910461Kong X, Ma Z, Tang R, Wang X, Wei K, Yang G, Yang Y, Zhao Y, Zhang D, Xie C, Wang G, Ma X. Efficacy of acupuncture in patients with mild Alzheimer's disease and its impact on gut microbiota: Study protocol for a randomized sham-controlled trial. Front Med (Lausanne). 2023 Feb 23;10:1014113. doi: 10.3389/fmed.2023.1014113. eCollection 2023.
PubMed 36910501
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05078944
- Acronym / sponsor ID
- ShanghaiIAMM2021052
- Conditions
- Alzheimer Disease 1
- Keywords
- Alzheimer's Disease, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
Detailed description
Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI).
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 |
|---|---|---|
| Active acupuncture + Donepezil | Experimental | Device: Active acupuncture, Drug: Donepezil HydrochlorideActive acupuncture treatment is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Acupuncture + Drug: Donepezil hydrochloride |
| Sham acupuncture + Donepezil | Sham comparator | Device: Sham acupuncture, Drug: Donepezil HydrochlorideSham acupuncture treatment with no skin penetration and no current output on sham acupoints is to be taken 3 sessions weekly over a period of 14 weeks. Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily over 32 weeks (including 4-week run-in) Intervention: Device: Sham acupuncture + Drug: Donepezil hydrochloride |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets the diagnostic criteria for probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
- Scored 1.0 by the Clinical Dementia Rating Scale (CDR) Global Score
Key exclusion criteria (12 listed)
- Dementia due to other causes
- Evidence of a clinically relevant or unstable psychiatric disorder
- Has irritable bowel syndrome or inflammatory bowel disease
- Has unstable or severe cardiovascular, hepatic, renal, respiratory, endocrinologic, neurologic diseases and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
- Has visual or hearing disorder, defeating completion of evaluation
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 |
|---|---|---|
| Active acupunctureAcupoints: Principal: GV20, EX-HN1, GV24 and bilateral PC6, HT7, ST36, KI3, SP6. Additional: CV6 and bilateral GB39, ST40, SP10 Sterile stainless steel disposable acupuncture needles (size 0.30 × 50 mm, Hwato brand, China) are used. After sterilization, a small plastic ring will be fixed over the acupuncture point with plaster to facilitate maintenance of blinding for the participant, and then the needle will be inserted through the plaster inside the ring. The electric stimulator (SDZ-Ⅲ electroacupuncture apparatus, Hwato brand, China) is applied to GV20, GV24, bilateral PC6 and HT7, dilatational wave, 10/50 Hz and tolerable electric current. Needles placed in other acupoints will be manually stimulated by rotation every 15 minutes. Each session lasts for 45 min. | Device | Active acupuncture + Donepezil |
| Sham acupunctureSham acupoints: SA1 (5 cun lateral to GV5), SA2 (5 cun lateral to GV4), SA3 (1 cun lateral to BL56). After sterilization, pragmatic placebo needles with blunt tip (size 0.30 × 50 mm, Hwato brand, China) are used. When their tips are pressed against the skin through plastic rings, participants will feel a pricking sensation. The electric stimulator is applied to bilateral SA1 and SA2 with no current output. The mental wire has been cut off with a same outlook as the electroacupuncture group. Needles placed in SA3 will be manually rotated every 15 minutes. Each session lasts for 45 min. | Device | Sham acupuncture + Donepezil |
| Donepezil HydrochlorideDonepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily. | Drug | Active acupuncture + Donepezil, Sham acupuncture + Donepezil |
Primary outcome
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
Time frame: Week 14
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 12 items (ranges from 0 to 75). Higher scores indicating greater cognitive impairment.
6 secondary outcomes
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame: Baseline, Week 7, Week 14, Week 21, Week 28
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
Time frame: Baseline, Week 7, Week 14, Week 21, Week 28
Change From Baseline in Neuropsychiatric Inventory (NPI)
Time frame: Baseline, Week 7, Week 14, Week 21, Week 28
Treatment Credibility
Time frame: Week 1, Week 14
Incidence of Adverse Events
Time frame: Week -4 to Week 28
Change in Gut Microbiota Diversity Based on 16S rRNA Gene Sequencing Analysis
Time frame: Baseline, Week 14, Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41910461Kong X, Han R, Fan X, Wei K, Ma Z, Yang G, Zhao Y, Yang Y, Yang Y, Hong J, Liu J, Zhang D, Ma X. Acupuncture as an adjunct therapy for mild Alzheimer's disease: A randomized clinical trial. J Alzheimers Dis. 2026 May;111(2):757-767. doi: 10.1177/13872877261435880. Epub 2026 Mar 30.
- Derived from this study: PubMed 36910501Kong X, Ma Z, Tang R, Wang X, Wei K, Yang G, Yang Y, Zhao Y, Zhang D, Xie C, Wang G, Ma X. Efficacy of acupuncture in patients with mild Alzheimer's disease and its impact on gut microbiota: Study protocol for a randomized sham-controlled trial. Front Med (Lausanne). 2023 Feb 23;10:1014113. doi: 10.3389/fmed.2023.1014113. eCollection 2023.
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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. This study is not recruiting at the moment.
Xiaopeng Ma, MD, PhD study chair
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active acupuncture and Donepezil Hydrochloride in people with Alzheimer Disease 1, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12) (time frame: Week 14). 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 NCT05078944, 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 22 May 2026.