Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)

NCT07262645 | Recruiting Phase 3

• 1 other identifier: NirsCure-03A
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 23

Brief Summary

This study is a multicenter, randomized, double-blind, placebo (sham device)-controlled clinical trial. A total of 320 patients with mild to moderate Alzheimer's disease (AD) are planned to be enrolled. Central stratified block randomization will be applied, with stratification based on disease severity (mild vs. moderate) and PET subgroup participation status (yes vs. no). Participants will be randomly assigned to either the treatment group or control group in a 1:1 ratio. After enrollment, participants will complete the treatment at home. The treatment group will receive therapy using a near-infrared light therapy device, while the control group will use sham device. Both investigators and participants will remain blinded to treatment allocation throughout the study.

Conditions

Alzheimer s Disease

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13)

  Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) score at 26-Weeks. The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating greater cognitive impairment.

  26 weeks

Secondary Outcomes (4)

• Clinical Dementia Rating - Sum of Boxes (CDR-SB)

  26 weeks

• Mini-Mental Status Examination (MMSE)

  26 weeks

• Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL)

  26 weeks

• Integrated Alzheimer's Disease Rating Scale (iADRS)

  26 weeks

Study Arms (2)

Sham device

SHAM COMPARATOR

Device: NirsCure 6000 sham device (once daily for 30 minutes, six times per week)

Device: Sham Device

Near infrared light therapy

EXPERIMENTAL

Device: NirsCure 6000 Near-infrared light therapy (once daily for 30 minutes, six times per week)

Device: NirsCure 6000

Interventions

NirsCure 6000 DEVICE

Near-infrared light therapy. Once daily for 30 minutes, six times per week.

Near infrared light therapy

Sham Device DEVICE

Sham device (once daily for 30 minutes, six times per week)

Sham device

Eligibility Criteria

• Age: 50 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged between 50 to 85 years old (inclusive).
• Participants must have at least 4 years of formal education and be capable of completing cognitive and other protocol-specified assessments.
• Documented progressive memory decline for ≥12 months prior to screening.
• Meets the core clinical diagnostic criteria for mild to moderate AD dementia (stages 4-5), according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) 2018 research framework and the AA workgroup 2024 update.
• Evidence of positive brain amyloid pathology, demonstrated by at least one of the following:
• Positive Aβ-PET scan (historical positive result acceptable); or
• Positive Cerebrospinal fluid (CSF) Aβ testing (historical positive result acceptable).
• Mini-Mental State Examination (MMSE) total score between 15 and 26 inclusive (between 12 and 22 for participants with an elementary school education level).
• Clinical Dementia Rating (CDR) Global of 1 or 2, and the CDR-Memory Box scores ≥ 0.5.
• If receiving acetylcholinesterase inhibitor or memantine, participants must be on a stable dose for at least 12 weeks prior to baseline.
• Must have at least one reliable study partner who can accompany the participant to complete daily treatment. The study partner should have a close relationship with the participant and sufficient knowledge to accurately report on cognition, function, behavior, safety, and protocol compliance. The study partner must be able to communicate with study staff via phone or WeChat, attend required on-site visit, provide informed consent to supporting follow-up throughout the study.
• The participant, study partner, or legally authorized representative voluntarily agrees to participate and provides written informed consent prior to any study procedures.

You may not qualify if:

• Presence of any diagnosis other than AD that could cause dementia or cognitive decline, including but not limited to: vascular dementia; Central nervous system infections (e.g., HIV, neurosyphilis); Creutzfeldt-Jakob disease; Huntington's disease; Parkinson's disease; Lewy body dementia; Traumatic brain injury-related dementia; Dementia caused by physical and chemical factors (e.g., drug toxicity, alcohol intoxication, carbon monoxide poisoning); significant systemic diseases (e.g., hepatic or pulmonary encephalopathy); Intracranial space-occupying lesions (e.g., subdural hematoma, brain tumors); or dementia clearly attributable to endocrine disorders, vitamin deficiencies, or other identifiable causes.
• Brain MRI demonstrating significant pathological findings, including but not limited to:
• More than two infarcts with a diameter \> 2 cm, or a single infarct involving critical regions (thalamus, hippocampus, entorhinal cortex, parahippocampal cortex, angular gyrus, or other cortical and subcortical gray matter nuclei);
• Extensive white matter hyperintensities (Fazekas score ≥ 3);
• History of transient ischemic attack (TIA), stroke, or seizure within 6 months of screening.
• Hachinski Ischemic Score (HIS) \> 4.
• Hamilton Depression Rating Scale (HAMD-17) total score \> 10.
• Diagnosis of a psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) at screening, including schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, or delirium.
• Known history or laboratory confirmation of HIV infection or neurosyphilis at screening.
• Severe cardiovascular disease, including New York Heart Association (NYHA) class III or IV heart function; Severe or unstable angina, or newly developed unstable angina within 3 months prior to screening (with objective clinical evidence such as cardiac enzyme abnormalities or dynamic ST-T changes on electrocardiogram); Acute myocardial infarction within 6 months prior to screening.
• Severe dysfunction of major organs (heart, lungs, liver, kidneys, etc.), or any medical condition that, in the opinion of the investigator, could render the participant unsuitable for this study or interfere with participation.
• Current or prior treatment with any anti-amyloid monoclonal antibody (e.g., aducanumab, lecanemab, or donanemab).
• Prior or planned lymphaticovenous anastomosis (LVA) of the cervical deep lymphatic vessels.
• Participation in any interventional clinical trial involving a drug or medical device within the 30 days prior to screening, except for observational studies or verified placebo-group participation in a previous interventional trial.
• History of severe head trauma or implanted cranial devices (e.g., bone screws, bone plates, prior cranial surgery, deep brain stimulators); Contraindications to MRI (e.g., claustrophobia, pacemakers/defibrillators, ferromagnetic metal implants); unwilling to undergo MRI examination.

Sponsors & Collaborators

• Danyang Huichuang Medical Equipment Co., Ltd.: lead

Study Sites (23)

Peking University First Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, 014040, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Tangdu Hospital, Air Force Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Pudong Hospital, Fudan University

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030001, China

RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

General Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310015, China

RECRUITING

Central Study Contacts

Yi Tang, MD, PhD

CONTACT

+86 13811021432; tangyi@xwhosp.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CN (23)