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This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease.
This experiment adopts a single-center, single-arm research design. All the patients who signed the informed consent were screened, and qualified subjects could only be enrolled to receive NIR therapy. This study plans to enroll 40 patients, all of whom meet the enrollment conditions will receive NIR therapy, and the treatment is arranged to be once a day, once a 30min NIR therapy, 6 times a week. The treatment lasted for 96 weeks, and follow-up and assessment were performed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. During the first week of treatment, caregivers will be trained in the use of the NIR device, and after the training is complete, researchers will also provide remote guidance, making visits as needed. Changes in the 96-week ADAS-cog score from baseline were used as the primary endpoint to verify the efficacy and safety of the NIR device.
Age
50 - 90 years
Sex
ALL
Healthy Volunteers
No
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Start Date
October 30, 2025
Primary Completion Date
January 1, 2030
Completion Date
December 31, 2030
Last Updated
September 15, 2025
40
ESTIMATED participants
Near infrared light therapy
DEVICE
Lead Sponsor
Xuanwu Hospital, Beijing
NCT04123314
NCT07178210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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