N/A N=160 Randomized Triple-blind Treatment

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

Alzheimer Disease 1

Bottom Line

View on ClinicalTrials.gov: NCT05078944 ↗

Enrolled (actual)

160

Serious AEs

0.6%

Results posted

May 2026

Primary outcome: Primary: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12) — -1.20; 0.36 point

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active acupuncture (Device); Sham acupuncture (Device); Donepezil Hydrochloride (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Primary completion: Sep 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)	-1.20; 0.36	—
SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE)	—	—
SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)	—	—
SECONDARY Change From Baseline in Neuropsychiatric Inventory (NPI)	—	—
SECONDARY Treatment Credibility	—	—
SECONDARY Incidence of Adverse Events	—	—
SECONDARY Change in Gut Microbiota Diversity Based on 16S rRNA Gene Sequencing Analysis	—	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05078944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.