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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07262645). This is a study registration, not published results. Lead sponsor: Danyang Huichuang Medical Equipment Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Alzheimer s Disease. Interventions: DEVICE: NirsCure 6000; DEVICE: Sham Device. Primary outcome measures: Alzheimer's Disease Assessment Scale, cognitive subscale 13 (ADAS-Cog13) , 52 weeks. Brief 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. 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.