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

NCT ID
NCT07835399
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Jun Xu
Conditions
Dementia, Mild Alzheimer Disease, Mild Cognitive Impairment (MCI)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 20 participants (Estimated).

What is being studied

  • Intervention: Laser Therapy
  • Intervention: Low-Level Light Therapy
  • Device: Photobiomodulation
  • Intervention: Phototherapy
  • Intervention: Therapeutics

Who may be eligible

Ages
50 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: China

Sample of listed locations

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

Study details

Start date
June 15, 2024
Primary completion date
December 31, 2026
Completion date
December 31, 2026
First posted
September 22, 2026
Collaborators
Shanghai Jinze Biotechnology Co. Ltd.

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07835399
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07835399 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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