AzTrials
AzTrials

Alzheimer s DiseasePhase 3NCT07262645

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

A Phase 3 study testing NirsCure 6000 in people with Alzheimer s Disease, run by Danyang Huichuang Medical Equipment Co., Ltd. at 23 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multicenter, randomized, double-blind, 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer s Disease
What is being tested?
NirsCure 6000
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
23 sitesChina
Study dates
10 Dec 2025to 22 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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);
  • Space-occupying lesions such as abscesses or brain tumors. Lesions judged by the investigator to have no clear clinical significance do not require exclusion.
  • History of transient ischemic attack (TIA), stroke, or seizure within 6 months of screening.
Show all 24Show fewer
  • 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.
  • Contraindications to PET or allergy to Aβ-PET tracer (except participants enrolled based solely on CSF Aβ positivity). Participants with uncontrolled abnormal blood glucose, allergy to FDG tracer, or any other investigator-judged contraindications are ineligible for the FDG-PET substudy.
  • History of malignancy within 5 years prior to screening, except for:
  • Adequately treated basal or squamous cell skin carcinoma, or cervical dysplasia;
  • Adequately treated Stage I in situ cervical cancer ≥ 2 years prior to screening without recurrence;
  • Prostate cancer confined to the prostate, adequately treated (e.g., surgery, radiotherapy, or active surveillance), with stable prostate-specific antigen (PSA) levels for ≥ 2 years prior to screening;
  • Non-metastatic breast cancer, adequately treated and without recurrence.
  • Women who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential not using highly effective contraception.
  • Any other condition that, in the opinion of the investigator, may compromise the participant's safety, interfere with protocol adherence, or confound study results.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Tang, MD, PhD contact

+86 13811021432

tangyi@xwhosp.org

23 sites in 1 country

China23 sites, 23 recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014040

    Furu Liang, MD, PhD, +86 13664077877

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100032

    Yongan Sun, MD, PhD, +86 13391705678

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Yongbo Zhang, MD, PhD, +86 13552909549

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Yi Tang, MD, PhD, +86 13811021432, tangyi@xwhosp.org

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Weizhong Xiao, MD, PhD, +86 15611908691

    Recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730

    Jing Yuan, MD, PhD, +86 18601105034

    Recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Baorong Zhang, MD, PhD, +86 13958167260

    Recruiting

  • Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang, 310015

    Jinghua Wang, MD, PhD, +86 15068892292

    Recruiting

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

    Xia Li, MD, PhD, +86 13774272543

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Qianhua Zhao, MD, PhD

    Recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Qun Xu, MD, PhD, +86 13301679717

    Recruiting

  • Pudong Hospital, Fudan University

    Shanghai, Shanghai Municipality, 201399

    Yunxia Li, MD, PhD, +86 13636370312

    Recruiting

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, 050000

    Jianping Zhang, MD, PhD, +86 17603116783

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Chunfeng Liu, MD, PhD, +86 13606210609

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Qun Xue, MD, PhD, +86 13013813620

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030001

    Xiaolei Liu, MD, PhD, +86 13934643261

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Yang Li, MD, PhD, +86 15035182003

    Recruiting

  • General Hospital, Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

    Nan Zhang, MD, PhD, +86 13752128310

    Recruiting

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300060

    Pan Li, MD, PhD, +86 13114881943

    Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

    Meiyun Zhang, MD, PhD, +86 13102017703

    Recruiting

  • Tangdu Hospital, Air Force Medical University

    Xi'an, Shaanxi, 710038

    Wei Zhang, MD， PhD, +86 13891955100

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Jin Wang, MD, PhD, +86 13572208524

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

    Rui Li, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Sham-Controlled Study on The Efficacy And Safety of Near-Infrared Light Therapy Device in Participants With Mild-Moderate Alzheimer's Disease (NirsCure-03A)

This study is a multicenter, randomized, double-blind, 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 Aβ-PET subgroup center 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 during a 52-week double-blind period. 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 double-blind period. Participants who complete the 52-week double-blind treatment period may choose to enter an open-label extension and receive an additional 26 weeks of active near-infrared light therapy.

Being tested
NirsCure 6000, Sham Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NirsCure 6000Device

    Near-infrared light therapy for 52 weeks during the double-blind period (once daily for 30 minutes, six times per week). Participants entering the open-label extension will receive an additional 26 weeks of active treatment with the same regimen.

  • Sham DeviceDevice

    Sham device for 52 weeks during the double-blind period (once daily for 30 minutes, six times per week). Participants entering the open-label extension will receive active near-infrared light therapy for an additional 26 weeks.

Study groups in NCT07262645
Study groupRoleWhat they receive
Sham deviceSham comparatorDevice: NirsCure 6000 sham device (once daily for 30 minutes, six times per week)
Receives: Device: Sham Device
Near infrared light therapyExperimentalDevice: NirsCure 6000 Near-infrared light therapy (once daily for 30 minutes, six times per week)
Receives: Device: NirsCure 6000

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 52-Weeks. The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating greater cognitive impairment.

    Measured: 52 weeks

Secondary outcomes (10)

  1. Integrated Alzheimer's Disease Rating Scale (iADRS)

    Change from baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) score at 52-Weeks. The iADRS score ranges from 0 to 144, with higher scores indicating better overall cognitive and functional performance.

    Measured: 52 weeks

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

    Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at 52-Weeks. The ADCS-ADL score ranges from 0 to 78, with higher scores indicating better functional ability in activities of daily living.

    Measured: 52 weeks

  3. Clinical Dementia Rating - Sum of Boxes (CDR-SB)

    Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at 52-Weeks. The CDR-SB score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment.

    Measured: 52 weeks

  4. Mini-Mental Status Examination (MMSE)

    Change from baseline in Mini-Mental State Examination (MMSE) score at 52-Weeks. The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.

    Measured: 52 weeks

  5. ADAS-Cog13

    Change from baseline in the ADAS-Cog13 at Week 13, 26 and 39

    Measured: 13, 26 and 39 weeks

  6. ADAS-Cog13

    Change from baseline in the ADAS-Cog13 at Week 81

    Measured: 81 weeks

  7. iADRS

    Change from baseline in the iADRS at Week 81

    Measured: 81 weeks

  8. ADCS-ADL

    Change from baseline in the ADCS-ADL at Week 81

    Measured: 81 weeks

  9. CDR-SB

    Change from baseline in the CDR-SB at Week 81

    Measured: 81 weeks

  10. MMSE

    Change from baseline in the MMSE at Week 81

    Measured: 81 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start10 Dec 2025
  3. Primary completion22 Jul 2027 (estimated)
  4. Study completion22 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262645
Sponsor's protocol ID
NirsCure-03A
Status last verified
Sep 2026
First submitted
21 Nov 2025
Last updated
22 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NirsCure 6000 in people with Alzheimer s Disease, run by Danyang Huichuang Medical Equipment Co., Ltd. at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Tang, MD, PhD (+86 13811021432, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in