Photobiomodulation therapy for mild cognitive impairment and mild Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind study evaluating the safety and potential cognitive benefits of at-home photobiomodulation therapy using near-infrared light. Participants are assigned 1:1 to active PBMT or a sham device that looks and feels the same but delivers non-active light for 6 months, with daily 20-minute sessions five days per week. Assessments include cognitive, mood, sleep, and daily-function measures, plus MRI scans at baseline, 3 months, and 6 months. The study explores the biological basis of PBMT in neurodegeneration and uses a rigorous blinding and adherence-monitoring design. Eligible adults are 50–85 years old with MCI or probable AD dementia, and study partners participate throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Qiwei Ren
• Email: renqiwei0828@163.com
• Phone: 86-16619725364

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.