Clinical trial
Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
Name
ShanghaiIAMM2021052
Description
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.
Trial arms
Trial start
2022-06-30
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Recruiting
Treatment
Active acupuncture
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.
Arms:
Active acupuncture + Donepezil
Sham acupuncture
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.
Arms:
Sham acupuncture + Donepezil
Donepezil Hydrochloride
Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.
Arms:
Active acupuncture + Donepezil, Sham acupuncture + Donepezil
Size
240
Primary endpoint
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 12 Item Subscore (ADAS-Cog12)
Baseline, Week 7, Week 14, Week 21, Week 28
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2024-05-30
1 organization
1 product
1 indication
Product
DonepezilIndication
Alzheimer Disease