NCT07262645
Recruiting
Phase 3
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)
Danyang Huichuang Medical Equipment Co., Ltd.23 sites in 1 country320 target enrollmentStarted: December 15, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Danyang Huichuang Medical Equipment Co., Ltd.
- Enrollment
- 320
- Locations
- 23
- Primary Endpoint
- Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •If receiving acetylcholinesterase inhibitor or memantine, participants must be on a stable dose for at least 12 weeks prior to baseline.
Exclusion Criteria
- •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 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) \>
- •Hamilton Depression Rating Scale (HAMD-17) total score \>
- •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.
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13)
Time Frame: 26 weeks
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.
Secondary Outcomes
- Clinical Dementia Rating - Sum of Boxes (CDR-SB)(26 weeks)
- Mini-Mental Status Examination (MMSE)(26 weeks)
- Integrated Alzheimer's Disease Rating Scale (iADRS)(26 weeks)
- Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL)(26 weeks)
Investigators
Study Sites (23)
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