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NCT06992804

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

Recruiting now EARLY_PHASE1 Last updated 9 September 2025
What this trial tests

EARLY_PHASE1 trial testing NirsCure with Lecanemab in Alzheimer Disease in 20 participants. Currently enrolling.

Timeline
28 May 2025
Primary endpoint
15 October 2025
20 January 2027

Quick facts

Lead sponsorXuanwu Hospital, Beijing
PhaseEARLY_PHASE1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment20
Start date28 May 2025
Primary completion15 October 2025
Estimated completion20 January 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xuanwu Hospital, Beijing

Who can join

Adults 50 to 90, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other Xuanwu Hospital, Beijing trials

Trials by the same sponsor.

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Data sources for this page

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