Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease

Eligibility criteria

1、Inclusion Criteria：
1. Age 50-85 years
2. Meet the 2011 NIA-AA diagnostic criteria for "MCI due to AD" or "probable AD dementia," or meet the 2018 NIA-AA "ATN" diagnostic framework for AD；
3. 0.5 ≤ CDR ≤ 2; for illiterate: MMSE ≤ 13; for primary school education: MMSE ≤ 19; for junior high school or above: MMSE ≤ 24; for MCI: ADL-20 ≤ 22; for mild AD: ADL-20 > 22；
4. Able to understand instructions and cooperate with serological tests, scale assessments, and brain MRI；
5. Have a study partner who can participate throughout the study。
2、Exclusion Criteria：
1. Inability to complete serological tests, scale assessments, or brain MRI due to severe visual/auditory impairment, severe neuropsychiatric symptoms, contraindications to MRI, etc.
2. History of other central nervous system injuries causing cognitive decline (e.g., severe traumatic brain injury, severe CNS infection, carbon monoxide poisoning, alcohol abuse, primary CNS tumors)
3. Unstable or severe heart, lung, liver, kidney, or hematopoietic diseases, poor general health
4. Short life expectancy due to major diseases (e.g., end-stage metastatic cancer cachexia)
5. Large skin lesions or scars on the scalp, or poor heat dissipation that cannot tolerate PBMT
6. Patients with photosensitivity disorders
7. Abnormal nasal structure (deviated septum or large polyps); bacterial or viral infection; nasal dryness/bleeding; nasopharyngeal carcinoma unsuitable for intranasal device insertion.

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 2026-09-22