RecruitingEarly Phase 1NCT06992804

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

20 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining near-infrared light therapy (a type of gentle light treatment applied to the head) with the Alzheimer's drug lecanemab can slow cognitive decline in people with mild Alzheimer's disease. **You may be eligible if...** - You are aged 50–90 years - You have been diagnosed with probable Alzheimer's disease - An amyloid PET scan has confirmed abnormal amyloid deposits in your brain - Your cognitive impairment is mild (CDR global score of 1, MMSE score of 15 or higher) - You have a caregiver who can help you with daily device use and assessments **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's (e.g., vascular dementia only, psychiatric illness) - You carry two copies of the APOE ε4 gene - You have more than 5 tiny bleeds in the brain on MRI - You are on blood thinners - You have had epilepsy or a bleeding stroke in the past year - You have an allergy to light or implanted metal devices in your head Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNirsCure with Lecanemab

Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).

OTHERsham 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).

OTHERNirsCure 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

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NCT06992804


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