RecruitingPhase 3NCT07262645

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)

Sponsor

Danyang Huichuang Medical Equipment Co., Ltd.

Enrollment

320 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable near-infrared (NIR) light therapy device — which delivers safe, low-level light to the scalp and brain — can slow memory and thinking decline in people with mild to moderate Alzheimer's disease. **You may be eligible if...** - You are between 50 and 85 years old - You have at least 4 years of formal education and can complete cognitive assessments - You have had progressively worsening memory for at least 12 months - You have a confirmed diagnosis of mild to moderate Alzheimer's disease (stages 4–5) with brain imaging or biomarker evidence of amyloid protein buildup **You may NOT be eligible if...** - Your cognitive decline is due to another condition (stroke, Parkinson's, etc.) - You have a pacemaker or metal implants near your head that would be unsafe with light therapy - You have severe Alzheimer's (stage 6 or 7) - You are on certain medications that affect the study outcomes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENirsCure 6000

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

DEVICESham Device

Sham device (once daily for 30 minutes, six times per week)