Randomized, Blinded, Sham-Controlled Trial of Acupuncture on the Progression of Mild Alzheimer's Disease
Status: Completed
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To determine if adjunctive acupuncture acts as an AD treatment rather than a placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization
Shanghai
Time Frame
Start Date: 2022-06-30
Completion Date: 2025-09-10
Participants
Target number of participants: 160
Treatments
Experimental: Active 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_comparator: Sham acupuncture + Donepezil
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
Related Therapeutic Areas
Sponsors
Leads: Shanghai Institute of Acupuncture, Moxibustion and Meridian