MedTrace Logo

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

NCT07262645 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-12-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Danyang Huichuang Medical Equipment Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-07-22
Completion
2027-07-22

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262645 on ClinicalTrials.gov