NCT07262645

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Danyang Huichuang Medical Equipment Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer s Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-07-22
• Completion: 2027-07-22
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

23 sites across 1 country: China