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New treatment option for Alzheimer s Disease
Official title Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)
ClinicalTrials.gov ID: NCT07262645
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join 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...
- Evidence of positive brain amyloid pathology, demonstrated by at least one of the following:
You likely can't join if
- Presence of any diagnosis other than AD that could cause dementia or cognitive decline, including but not limited to: vascular dementia; Central...
- 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...
- Extensive white matter hyperintensities (Fazekas score ≥ 3);
- Space-occupying lesions such as cysts, abscesses, or brain tumors (e.g., meningiomas or arachnoid cysts). Specifically, meningiomas or arachnoid...
- History of transient ischemic attack (TIA), stroke, or seizure within 6 months of screening.
See the full eligibility criteria
Who can 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...
- 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...
- The participant, study partner, or legally authorized representative voluntarily agrees to participate and provides written informed consent prior to any study procedures.
What rules you out
- 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...
- 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...
- Extensive white matter hyperintensities (Fazekas score ≥ 3);
- Space-occupying lesions such as cysts, abscesses, or brain tumors (e.g., meningiomas or arachnoid cysts). Specifically, meningiomas or arachnoid cysts with a maximum diameter \< 1 cm do not require exclusion.
- 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...
- 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...
- 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...
- 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 treatment 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 treatment...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shijiazhuang, Hebei, China
- Baotou, Inner Mongolia, China
- Suzhou, Jiangsu, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shijiazhuang, Hebei, China; Baotou, Inner Mongolia, China; Suzhou, Jiangsu, China; Xi'an, Shaanxi, China; Shanghai, Shanghai Municipality, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.