Acupuncture for Mild Alzheimer's Disease Treatment
Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
NA · Shanghai Institute of Acupuncture, Moxibustion and Meridian · NCT05078944
This study is testing whether acupuncture can help people with mild Alzheimer's disease feel better when combined with their usual medication, compared to a fake acupuncture treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Institute of Acupuncture, Moxibustion and Meridian (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05078944 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of acupuncture as an adjunctive therapy for patients with mild Alzheimer's disease, comparing it to a sham acupuncture treatment. It aims to determine if acupuncture can provide real benefits beyond placebo effects and whether these benefits are associated with changes in gut microbiota. The trial involves 160 participants who will receive either active or sham acupuncture three times a week for 14 weeks, alongside a standard donepezil treatment. The primary outcome will be measured using the Alzheimer's Disease Assessment Scale, with secondary outcomes including cognitive and daily living assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild Alzheimer's disease who meet specific inclusion criteria.
Not a fit: Patients with dementia due to other causes or those with significant comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing mild Alzheimer's disease symptoms.
How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach linking it to gut microbiota in Alzheimer's treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Xiehe Kong, MD
- Email: ynomrahkong@163.com
- Phone: +8613621775647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease 1, Alzheimer's Disease, Electroacupuncture