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

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Enrolling

Conditions: Alzheimer Disease 1

Treatments: Device: Active acupuncture; Device: Sham acupuncture; Drug: Donepezil Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05078944

ShanghaiIAMM2021052

Details and patient eligibility

About

To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.

Full description

Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. Growing studies suggest that resident gut microbiota contributes to the development and progression of AD. Acupuncture is reported to treat gastrointestinal and neurodegenerative disorders via the gut-brain axis. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.

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 to week 28 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) and gut microbiota.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Active acupuncture + Donepezil

Experimental group

Description:

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

Treatment:

Drug: Donepezil Hydrochloride

Device: Active acupuncture

Sham acupuncture + Donepezil

Sham Comparator group

Description:

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

Treatment:

Drug: Donepezil Hydrochloride

Device: Sham acupuncture