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

NCT07835399 | Recruiting DMC

• 1 other identifier: JX-JZQ2024-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment (MCI); Mild Alzheimer Disease; Dementia

Keywords

Photobiomodulation; Transcranial photobiomodulation; Near-infrared light therapy; Alzheimer's disease; Mild cognitive impairment; Dementia;; Neuromodulation

Outcome Measures

Primary Outcomes (5)

• Mini-Mental State Examination

  The Mini-Mental State Examination (MMSE) assesses orientation, registration, attention and calculation, recall, and language using 11 items. Total scores range from 0 to 30; lower scores indicate worse cognitive function and higher scores indicate better cognitive function.

  Baseline, Month 3, Month 6

• Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) assesses visuospatial and executive function, naming, attention, language, abstraction, delayed recall, and orientation. Total scores range from 0 to 30; higher scores indicate better cognitive function and lower scores indicate worse cognitive function.

  Baseline, Month 3, Month 6

• Alzheimer's Disease Assessment Scale-Cognitive Subscale

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale, 11-item version (ADAS-Cog-11), assesses cognitive domains including memory, language, orientation, and praxis. The total score ranges from 0 to 70, with 0 indicating the least cognitive impairment and 70 indicating the most severe cognitive impairment. Higher scores indicate worse cognitive function. A decrease in score indicates improvement, whereas an increase indicates worsening.

  Baseline, Month 3, Month 6

• Clinical Dementia Rating

  The Clinical Dementia Rating (CDR) assesses cognition and daily functioning. The CDR Sum of Boxes (CDR-SB) ranges from 0 to 18; higher scores indicate greater impairment. The global CDR score ranges from 0 to 3: 0 = normal, 0.5 = questionable, 1 = mild, 2 = moderate, and 3 = severe; higher scores indicate worse outcomes.

  Baseline, Month 3, Month 6

• Magnetic Resonance Imaging

  Magnetic resonance imaging (MRI) compares differences in cortical/hippocampal atrophy, white matter degeneration, and cerebral blood flow perfusion before and after treatment.

  Baseline, Month 3, Month 6

Secondary Outcomes (6)

• Hamilton Depression Rating Scale

  Baseline, Month 3, Month 6

• Hamilton Anxiety Rating Scale

  Baseline, Month 3, Month 6

• Neuropsychiatric Inventory

  Baseline, Month 3, Month 6

• Pittsburgh Sleep Quality Index

  Baseline, Month 3, Month 6

• Activities of Daily Living Scale

  Baseline, Month 3, Month 6

Study Arms (2)

Active PBMT

EXPERIMENTAL

Use the transcranial photobiomodulation device at 810 nm once daily for 20 minutes per session, for 5 consecutive days, followed by 2 days off.

Device: Photobiomodulation

Sham PBMT

SHAM COMPARATOR

Use the transcranial photobiomodulation device at 660 nm once daily for 20 minutes per session, for 5 consecutive days, followed by 2 days off.

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

transcranial photobiomodulation

Active PBMT

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• ≤ 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。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun Xu: lead
• Shanghai Jinze Biotechnology Co. Ltd.: collaborator

Study Sites (1)

Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Qiwei Ren

CONTACT

86-16619725364; renqiwei0828@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Professor, Department of Cognitive Disorders

Model Details: Participants are randomized 1:1 to one of two parallel arms-active PBMT or sham-and remain in their assigned arm for the 6-month treatment period.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: September 22, 2026
• Study Start: June 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication, all IPD and supporting information will be made available.
• Access Criteria: All information regarding participants' data on primary and secondary outcome measurements will be used in publication.

Locations

CN (1)