Clinical Trial

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

Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07262645
Lead Sponsor Danyang Huichuang Medical Equipment Co., Ltd.
Conditions Alzheimer s Disease
Enrollment 320 participants
Start Date 2025-12-15
Primary Completion 2027-07-22 (estimated)
Study Completion 2027-07-22 (estimated)
Updated on ClinicalTrials.gov 2025-12-03