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Transcranial Near-infrared Light Therapy for Mild-Moderate Alzheimer's Disease (NIR4AD)

NCT06160908 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this study is to explore the efficacy and safety of Near-infrared light Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD).

This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and extension phase. In the core phase, qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment. The subjects who entered the control group received 30 minutes of non-near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks. After finishing 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 receive active near-infrared light therapy until week 196.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

NirsCure

True near-infrared light； Once a day, once for 30 minutes, 6 times a week

DEVICE

sham NirsCure

Non near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week

DEVICE

NirsCure

True near-infrared light； Once a day, once for 30 minutes, 6 times a week

Sponsors & Collaborators

  • Danyang Huichuang Medical Equipment Co., Ltd.

    collaborator INDUSTRY

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-08-25
Completion
2028-06-30

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 NCT06160908 on ClinicalTrials.gov