NCT06992804

Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• 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 combined with lecanemab in patients with mild Alzheimer's disease (AD). This study will employ a randomized, double-blind, sham-controlled method with an open-label extension phase. This trial contains the core phase and an extension phase. During the core phase, eligible subjects were selected and randomized (experimental group: control group = 1:1). The subjects who entered the experimental group received treatment with a near-infrared light therapy device combined with lecanemab for 16 weeks. The subjects who entered the control group received treatment with a near-infrared light therapy device simulator (sham stimulation) combined with lecanemab for 16 weeks. After completing 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 were treated with a near-infrared light therapy device combined with lecanemab up to week 48.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
OTHER	NirsCure with Lecanemab	Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).
OTHER	sham NirsCure with Lecanemab	Sham near-infrared light therapy (where only the equipment appearance is consistent with the true near infrared light device, one session per day, 30 minutes per session, 6 sessions per week) in combined with lecanemab (10mg/kg).
OTHER	NirsCure with Lecanemab	Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).

Timeline

• Start date: 2025-05-28
• Primary completion: 2025-10-15
• Completion: 2027-01-20
• First posted: 2025-05-28
• Last updated: 2025-09-09

Locations

1 site across 1 country: China