NCT07835399Recruiting

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

Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease, A 6-Month, Single-Center, Randomized, Double-Blind, Controlled Trial

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if photobiomodulation therapy (PBMT) can help treat mild cognitive impairment and mild Alzheimer's disease in adults aged 50 to 85 years. It will also learn about the safety of PBMT. The main questions it aims to answer are: Does PBMT improve cognitive function in adults with mild cognitive impairment or mild Alzheimer's disease? What medical problems do participants have when using PBMT? Researchers will compare an active PBMT device to a sham (look-alike) device that delivers no active light therapy to see if PBMT improves cognitive function. Participants will: Use a transcranial near-infrared light therapy device (or a matching sham device) once a day for 20 minutes, 5 days a week, for 6 months Visit the clinic for cognitive, mood, sleep, and daily-function assessments at the start of the study, at Month 3, and at Month 6 Have brain MRI scans at the start of the study, at Month 3, and at Month 6

Status (registry): Recruiting
Study type: Interventional
Enrollment: 20 (estimated)
First submitted: 23 Jun 2026
Start date: 15 Jun 2024
Primary completion date: 31 Dec 2026
Lead sponsor: Jun Xu
Diseases: Alzheimer disease
NCT number: NCT07835399

What you commit to

Study type: Interventional
Planned participants: 20
From 15 Jun 2024 to the primary completion date, 31 Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

1、Inclusion Criteria：
Age 50-85 years
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；
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；
Able to understand instructions and cooperate with serological tests, scale assessments, and brain MRI；
Have a study partner who can participate throughout the study。
- 2、Exclusion Criteria：
Inability to complete serological tests, scale assessments, or brain MRI due to severe visual/auditory impairment, severe neuropsychiatric symptoms, contraindications to MRI, etc.
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)
Unstable or severe heart, lung, liver, kidney, or hematopoietic diseases, poor general health
Short life expectancy due to major diseases (e.g., end-stage metastatic cancer cachexia)
Large skin lesions or scars on the scalp, or poor heat dissipation that cannot tolerate PBMT
Patients with photosensitivity disorders
Abnormal nasal structure (deviated septum or large polyps); bacterial or viral infection; nasal dryness/bleeding; nasopharyngeal carcinoma unsuitable for intranasal device insertion.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical University Coordinator of this site? Confirm its status	Beijing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.