NCT06160908

Transcranial Near-infrared Light Therapy for Mild-Moderate Alzheimer's Disease (NIR4AD)

The Safety and Efficacy of Transcranial Near-infrared Light in the Treatment of Mild-Moderate Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to explore the efficacy and safety of Near-infrared light Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD). This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and extension phase. In the core phase, qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment. The subjects who entered the control group received 30 minutes of non-near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks. After finishing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants receive active near-infrared light therapy until week 196.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	NirsCure	True near-infrared light； Once a day, once for 30 minutes, 6 times a week
DEVICE	sham NirsCure	Non near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week
DEVICE	NirsCure	True near-infrared light； Once a day, once for 30 minutes, 6 times a week

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-08-25
• Completion: 2028-06-30
• First posted: 2023-12-07
• Last updated: 2026-04-13

Locations

1 site across 1 country: China