Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

NCT05078944 | Completed Results DMC

• 1 other identifier: ShanghaiIAMM2021052
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.

Conditions

Alzheimer Disease 1

Keywords

Alzheimer's Disease; Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change From Baseline in Mini-Mental State Examination (MMSE)

  Baseline, Week 7, Week 14, Week 21, Week 28

• Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)

  Baseline, Week 7, Week 14, Week 21, Week 28

• Change From Baseline in Neuropsychiatric Inventory (NPI)

  Baseline, Week 7, Week 14, Week 21, Week 28

• Treatment Credibility

  Week 1, Week 14

• Incidence of Adverse Events

  Week -4 to Week 28

Study Arms (2)

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

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

Device: Sham acupuncture; Drug: Donepezil Hydrochloride

Interventions

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.

Active acupuncture + Donepezil

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.

Sham acupuncture + Donepezil

Donepezil Hydrochloride DRUG

Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.

Active acupuncture + Donepezil; Sham acupuncture + Donepezil

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization

Shanghai, 200030, China

Location

Related Publications (2)

• 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 Mar 30:13872877261435880. doi: 10.1177/13872877261435880. Online ahead of print.

  PMID: 41910461 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.

  PMID: 36910501 DERIVED

MeSH Terms

Conditions

Alzheimer disease type 1; Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Xiaopeng Ma
• Organization: Shanghai Research Institute of Acupuncture and Meridian

maxiaopeng@shutcm.edu.cn

02164690257

Study Officials

• Xiaopeng Ma, MD, PhD

  Shanghai Institute of Acupuncture, Moxibustion and Meridian

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 15, 2021
• Study Start: June 30, 2022
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Locations

CN (1)