Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07262645
PHASE3

Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)

Sponsor: Danyang Huichuang Medical Equipment Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

NirsCure 6000

Near-infrared light therapy. Once daily for 30 minutes, six times per week.

DEVICE

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