Clinical trial NCT05078944: Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture
Official title: Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease 1
Keywords: Alzheimer's Disease
Electroacupuncture
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
timeFrame: Baseline, Week 7, Week 14, Week 21, Week 28
Secondary outcomes:
measure: Change in gut microbiota diversity based on 16S rRNA gene sequencing analysis
timeFrame: Baseline, Week 14, Week 28
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline, Week 7, Week 14, Week 21, Week 28
measure: Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline, Week 7, Week 14, Week 21, Week 28
measure: Change From Baseline in Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, Week 7, Week 14, Week 21, Week 28
measure: Treatment credibility
timeFrame: Week 1, Week 14
measure: Incidence of adverse events
timeFrame: Week -4 to Week 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Xiaopeng Ma, MD, PhD
role: STUDY_CHAIR
References: