Skip to main content
OpenTrials
Completed

NCT Number: NCT05078944

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease 1 Alzheimer Disease Alzheimer disease type 1 Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization

Shanghai, 200030, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline, Week 7, Week 14, Week 21, Week 28

    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.

  2. 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

    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.

  3. Change From Baseline in Neuropsychiatric Inventory (NPI)

    Time frame: Baseline, Week 7, Week 14, Week 21, Week 28

    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

  4. Treatment Credibility

    Time frame: Week 1, Week 14

    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.

  5. Incidence of Adverse Events

    Time frame: Week -4 to Week 28

    Including subcutaneous hematoma, local errhysis at acupoints, sharp pain, palpitation, nausea, dizziness and faint during acupuncture.

  6. Change in Gut Microbiota Diversity Based on 16S rRNA Gene Sequencing Analysis

    Time frame: Baseline, Week 14, Week 28

    Stool samples will be processed to extract DNA, followed by 16S rRNA gene sequencing analysis using QIIME and R packages (v3.2.0).

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.