Alzheimer DiseaseNCT06417086
Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers
A study testing Acupuncture and Donepezil in people with Alzheimer Disease and Cognitive Impairment, run by ZhanYJ at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- What is being tested?
- Acupuncture and Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Nov 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 50-85 years
- Diagnosed by the 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
- Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
- Anticoagulant treatments such as warfarin or heparin
- Use of pacemakers or receiving acupuncture in the past 2 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
Yijun Zhan, +8618917699167, jenniferzhan_lhzj@163.com
About this study
Official title: Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial
The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.
Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.
Read more
Participants will:
Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.
Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.
Read the detailed description
This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Being tested
- Acupuncture, Sham Acupuncture, Donepezil
- 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. There will be 12 weeks of 3-session treatment for each participant in total.
Sham AcupunctureOther
The Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. 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. There will be 12 weeks of 3-session treatment for each participant in total.
DonepezilDrug
Donepezil 5 mg will be given once daily before bed-time for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Treatment | Experimental | Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks. Receives: Other: Acupuncture; Drug: Donepezil |
| Sham Acupuncture Treatment | Active comparator | Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks. Receives: Other: Sham Acupuncture; 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 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: Change from baseline to Week 12
Secondary outcomes (3)
Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)
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: Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)
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: Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Quality of Life-Alzheimer's Disease(QOL-AD)
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: Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZhanYJ
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Minimally Invasive Surgery Center
- Responsible party
- Sponsor-investigator, ZhanYJ, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yijun Zhan, Study chair, Shanghai University of Traditional Chinese MedicineHouguang Zhou, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417086
- Sponsor's protocol ID
- 23Y11921000
- Status last verified
- May 2025
- First submitted
- 12 May 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06417086
- Acronym / sponsor ID
- 23Y11921000
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- ZhanYJUniversity, hospital or other
- Collaborators
- Shanghai Minimally Invasive Surgery Center
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 May 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 goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.
Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.
Participants will:
Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.
Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.
Detailed description
This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Treatment | Experimental | Other: Acupuncture, Drug: DonepezilParticipants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks. |
| Sham Acupuncture Treatment | Active comparator | Other: Sham Acupuncture, Drug: DonepezilParticipants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 50-85 years
- Diagnosed by the 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 (6 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
- Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
- Anticoagulant treatments such as warfarin or heparin
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. There will be 12 weeks of 3-session treatment for each participant in total. | Other | Acupuncture Treatment |
| Sham AcupunctureThe Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. 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. There will be 12 weeks of 3-session treatment for each participant in total. | Other | Sham Acupuncture Treatment |
| DonepezilDonepezil 5 mg will be given once daily before bed-time for 12 weeks. | Drug | Acupuncture Treatment, Sham Acupuncture Treatment |
Primary outcome
Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)
Time frame: Change from baseline to 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.
3 secondary outcomes
Alzheimer's Disease Assessment Scale-cognition (ADAS-cog)
Time frame: Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)
Time frame: Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
Quality of Life-Alzheimer's Disease(QOL-AD)
Time frame: Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2)
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 21 May 2025.
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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.
Yijun Zhan study chair
Shanghai University of Traditional Chinese Medicine
Houguang Zhou study director
Huashan Hospital
1 site 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 ZhanYJ 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 6 inclusion and 6 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 21 May 2025. 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. 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 Yijun Zhan (+8618917699167, jenniferzhan_lhzj@163.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: Change from baseline to Week 12). 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 21 May 2025.