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, 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.
• 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.