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RECRUITING
NCT06992804
EARLY_PHASE1

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

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-28

Completion Date

2027-01-20

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

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).

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China