Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 7, Week 14, Week 21, Week 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaopeng Ma, MD, PhD | Shanghai Institute of Acupuncture, Moxibustion and Meridian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization | Shanghai | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910461 | Derived | 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. | |
| 36910501 | Derived | Kong 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. |
Not provided
Not provided
Not provided
Of 192 patients screened, 160 were randomized between June 30, 2022, and January 20, 2025.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Acupuncture + Donepezil | 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 |
| FG001 | Sham Acupuncture + Donepezil | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Acupuncture + Donepezil | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment. | Posted | Mar 2027 | Mean | Standard Error | point | Week 14 |
|
from enrollment until end of follow-up, up to 28 weeks
Modified intention-to-treat analysis was adopted. Two in the Acive acupuncture + Donepezil group and 1 in the Sham acupuncture + Donepezil gruop were excluded from analysis due to lack of 1 valid postbasline assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Acupuncture + Donepezil | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Ma | Shanghai Research Institute of Acupuncture and Meridian | 02164690257 | maxiaopeng@shutcm.edu.cn |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2022 | Apr 28, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2022 | Apr 28, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C536594 | Alzheimer disease type 1 |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham acupuncture | Device | 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 Hydrochloride | Drug | Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily. |
|
| 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. | 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 | 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. | Week 1, Week 14 |
| Incidence of Adverse Events | Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture. | 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). | Baseline, Week 14, Week 28 |
| Sham Acupuncture + Donepezil |
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 |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Acetylcholinesterase inhibitor or memantine use history | Count of Participants | Participants |
|
| OG001 | Sham Acupuncture + Donepezil | 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 |
|
|
| Secondary | 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. | Not Posted | Mar 2027 | Baseline, Week 7, Week 14, Week 21, Week 28 | Participants |
| Secondary | 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. | Not Posted | Baseline, Week 7, Week 14, Week 21, Week 28 | Participants |
| Secondary | 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 | Not Posted | Baseline, Week 7, Week 14, Week 21, Week 28 | Participants |
| Secondary | 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. | Not Posted | Week 1, Week 14 | Participants |
| Secondary | Incidence of Adverse Events | Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture. | Not Posted | Week -4 to Week 28 | Participants |
| Secondary | 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). | Not Posted | Baseline, Week 14, Week 28 | Participants |
| 0 |
| 78 |
| 0 |
| 78 |
| 29 |
| 78 |
| EG001 | Sham Acupuncture + Donepezil | 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 | 0 | 79 | 1 | 79 | 35 | 79 |
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Subcutaneous hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Heart palpitations | Cardiac disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |