Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture
Alzheimer Disease 1
About this trial
This is an interventional treatment trial for Alzheimer Disease 1 focused on measuring Alzheimer's Disease, Electroacupuncture
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
Sites / Locations
- Shanghai Institute of Acupuncture, Moxibustion and Meridian OrganizationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active acupuncture + Donepezil
Sham acupuncture + Donepezil
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
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