NCT06836180 · Early Phase 1 · NOT YET RECRUITING
An Exploratory Study of Near-infrared Light Therapy for Mild to Moderate Alzheimer's Disease
This trial is testing a device that shines near-infrared light on the head as a possible way to help people who already have mild to moderate Alzheimer's disease. Researchers are measuring both whether it does anything helpful and whether it is safe. It is an Early Phase 1 study, meaning this is very preliminary — the researchers are exploring basic questions before larger trials could ever follow.
You may qualify if
- 50 - 90 years old, no gender limitation;
- Meeting the National Institute on Aging and Alzheimer's Association (2011 NIA-AA) is likely the core clinical diagnostic criteria for Alzheimer's disease;
- The MMSE score is ≥ 12 and ≤ 26;
- The subjects should have primary school education or above and be able to complete the cognitive ability measurement and other tests stipulated in the protocol;
- If taking cognitive-improving medications, the dose must be stable for at least 12 weeks prior to enrollment (stable for at least 4 weeks with psychotropic medications);
- Participants themselves or their guardians voluntarily participate and sign the informed consent.
You're excluded if
- Any cognitive impairment or dementia not caused by Alzheimer's disease, or co-existing with a serious mental illness (schizophrenia, bipolar disorder, major depression, etc.);
- Currently taking anticoagulant drugs;
- A history of seizures or hemorrhagic stroke within 12 months;
- Allergic to sunlight or visible light or high sensitivity to head and neck skin;
- Severe head trauma or implants (bone nails, bone plates, excision, etc.);
- Malignant tumors;
- Any other medical condition that is not stabilized and adequately controlled (such as serious heart, respiratory, gastrointestinal, or kidney disease), or that the investigator believes may affect patient safety or interfere with the evaluation of the test;
- Persons addicted to alcohol or drugs;
- Women who are pregnant, nursing or planning a pregnancy;
- Participated in other clinical studies within 1 month before participating in this trial;
- Other conditions deemed unsuitable for clinical trial participation by the investigator.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-15