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

NCT06992804 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-09

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Yi Tang, MD, PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2025-10-15
Completion
2027-01-20

Countries

  • China

Study Locations

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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 NCT06992804 on ClinicalTrials.gov