NCT05078944

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

Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.

Detailed description

Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo. 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 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).

Conditions

• Alzheimer Disease 1

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
DRUG	Donepezil Hydrochloride	Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.

Timeline

• Start date: 2022-06-30
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2021-10-15
• Last updated: 2025-10-01

Locations

1 site across 1 country: China