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Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)
Sponsor: Danyang Huichuang Medical Equipment Co., Ltd.
Summary
This study is a multicenter, randomized, double-blind, placebo (sham device)-controlled clinical trial. A total of 320 patients with mild to moderate Alzheimer's disease (AD) are planned to be enrolled. Central stratified block randomization will be applied, with stratification based on disease severity (mild vs. moderate) and PET subgroup participation status (yes vs. no). Participants will be randomly assigned to either the treatment group or control group in a 1:1 ratio. After enrollment, participants will complete the treatment at home. The treatment group will receive therapy using a near-infrared light therapy device, while the control group will use sham device. Both investigators and participants will remain blinded to treatment allocation throughout the study.
Official title: A Multicenter, Randomized, Double-Blind, Sham-Controlled Study on The Efficacy And Safety of Near-Infrared Light Therapy Device in Participants With Mild-Moderate Alzheimer's Disease (NirsCure-03A)
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2025-12-15
Completion Date
2027-07-22
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
NirsCure 6000
Near-infrared light therapy. Once daily for 30 minutes, six times per week.
Sham Device
Sham device (once daily for 30 minutes, six times per week)
Locations (23)
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Pudong Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China