| Field | Value |
|---|---|
| NCT Number | NCT07262645 |
| Status | Recruiting |
| Sponsor | Danyang Huichuang Medical Equipment Co., Ltd. |
| Phase | Phase 3 |
| Enrollment | 320 patients (estimated) |
| Start Date | December 2025 |
| Completion Date | July 2027 |
| Measure | Time Frame |
|---|---|
| ADAS-Cog13 (Alzheimer's Disease Assessment Scale, cognitive subscale 13) | 26 weeks |
The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating greater cognitive impairment.
| Measure | Time Frame |
|---|---|
| CDR-SB (Clinical Dementia Rating - Sum of Boxes) | 26 weeks |
| MMSE (Mini-Mental Status Examination) | 26 weeks |
| ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) | 26 weeks |
| iADRS (Integrated Alzheimer's Disease Rating Scale) | 26 weeks |
The trial is conducted at 21 sites across China:
| City | Hospital |
|---|---|
| Beijing | Peking University First Hospital |
| Beijing | Beijing Friendship Hospital |
| Beijing | Xuanwu Hospital, Capital Medical University |
| Beijing | Peking University Third Hospital |
| Beijing | Peking Union Medical College Hospital |
| Shijiazhuang | Shijiazhuang People's Hospital |
| Baotou | Baotou Central Hospital |
| Suzhou | Second Affiliated Hospital of Soochow University |
| Suzhou | First Affiliated Hospital of Soochow University |
| Xi'an | Tangdu Hospital, Air Force Medical University |
| Xi'an | First Affiliated Hospital of Xi'an Jiaotong University |
| Xi'an | Shaanxi Provincial People's Hospital |
| Shanghai | Shanghai Mental Health Center |
| Shanghai | Huashan Hospital, Fudan University |
| Shanghai | Renji Hospital, Shanghai Jiao Tong University |
| Shanghai | Pudong Hospital, Fudan University |
| Taiyuan | Shanxi Bethune Hospital |
| Taiyuan | First Hospital of Shanxi Medical University |
| Tianjin | General Hospital, Tianjin Medical University |
| Tianjin | Tianjin Huanhu Hospital |
| Tianjin | Tianjin People's Hospital |
| Hangzhou | Second Affiliated Hospital, Zhejiang University |
| Hangzhou | Affiliated Hospital of Hangzhou Normal University |
Photobiomodulation using near-infrared (NIR) light operates through distinct mechanisms from bright light therapy:
Near-infrared light offers advantages for Alzheimer's disease:
This Phase 3 trial represents a significant step for non-pharmacological neuroprotection in Alzheimer's disease: