Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorJun Xu
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
Devicetranscranial photobiomodulation
Photobiomodulation
Devicetranscranial photobiomodulation
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Active PBMTExperimental treatment 1 intervention
Group B: Sham PBMTSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Month 3, Month 62
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.
Time frame
Baseline, Month 3, Month 63
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.
Time frame
Baseline, Month 3, Month 64
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.
Time frame
Baseline, Month 3, Month 6Secondary outcomes
1
Hamilton Depression Rating Scale
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated assessment of depression severity covering mood, anxiety, somatic symptoms, cognition, sleep, and related symptoms. Total scores range from 0 to 52; higher scores indicate more severe depression and a worse outcome.
Time frame
Baseline, Month 3, Month 62
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HAMA) is a 14-item, clinician-rated assessment of psychic and somatic anxiety. Total scores range from 0 to 56; higher scores indicate greater anxiety severity and a worse outcome.
Time frame
Baseline, Month 3, Month 63
Neuropsychiatric Inventory
The Neuropsychiatric Inventory (NPI) assesses behavioral and psychological symptoms of dementia across 12 domains. It measures symptom frequency, severity, and caregiver distress. The total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms.
Time frame
Baseline, Month 3, Month 64
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item, self-rated assessment of sleep quality over the previous month across seven components. Total scores range from 0 to 21; higher scores indicate poorer sleep quality and a worse outcome.
Time frame
Baseline, Month 3, Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Xu
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Shanghai Jinze Biotechnology Co. Ltd.
Collaborator
Source ClinicalTrials.gov