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.
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.
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.
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.
Parallel
NirsCure 6000
DeviceNear-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 Device
DeviceSham 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.
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.
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.
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.
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.
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.
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