NCT06836180

An Exploratory Study of Near-infrared Light Therapy for Mild to Moderate Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease.

Detailed description

This experiment adopts a single-center, single-arm research design. All the patients who signed the informed consent were screened, and qualified subjects could only be enrolled to receive NIR therapy. This study plans to enroll 40 patients, all of whom meet the enrollment conditions will receive NIR therapy, and the treatment is arranged to be once a day, once a 30min NIR therapy, 6 times a week. The treatment lasted for 96 weeks, and follow-up and assessment were performed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. During the first week of treatment, caregivers will be trained in the use of the NIR device, and after the training is complete, researchers will also provide remote guidance, making visits as needed. Changes in the 96-week ADAS-cog score from baseline were used as the primary endpoint to verify the efficacy and safety of the NIR device.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Near infrared light therapy	Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks

Timeline

• Start date: 2025-10-30
• Primary completion: 2030-01-01
• Completion: 2030-12-31
• First posted: 2025-02-20
• Last updated: 2025-09-15

Locations

1 site across 1 country: China