Mild Cognitive Impairment (MCI)PBMT in MCINCT07835399
Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease
A study testing Photobiomodulation in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by Jun Xu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Alzheimer Disease, Dementia
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical University
Beijing
Qiwei Ren, 86-16619725364, renqiwei0828@163.com
JUN XU, Chief Physician, Professor
About this study
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
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.
Read more
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
Read the detailed description
Alzheimer's disease and its prodromal stage, mild cognitive impairment, are characterized by progressive neurodegeneration for which disease-modifying options remain limited. Photobiomodulation therapy (PBMT) delivers non-ionizing red and near-infrared light to neural tissue, where it is absorbed by cytochrome c oxidase in the mitochondrial respiratory chain. This is hypothesized to enhance ATP production, modulate reactive oxygen species and intracellular signaling, increase regional cerebral blood flow, and support neuroprotective and anti-inflammatory processes, providing the biological basis for evaluating PBMT as a non-invasive intervention in early Alzheimer's disease.
This is a single-center, prospective, randomized, double-blind, sham-controlled trial conducted at the Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical University. Eligible participants are randomly allocated in a 1:1 ratio to the active PBMT arm or the sham-control arm using a computer-generated randomization sequence. To preserve double blinding, the active and sham devices are identical in appearance and operation; the sham device emits visible light at a wavelength without established photobiomodulatory effect, so that neither participants nor outcome assessors can distinguish between arms. Treatment is self-administered at home according to a fixed schedule over the 6-month intervention period, with adherence monitored through device usage records and scheduled study visits.
Assessments are performed at baseline, Month 3, and Month 6 by trained raters blinded to group allocation. Beyond the clinical and neuropsychological battery, structural and functional MRI is used to examine treatment-associated changes in cortical and hippocampal volume, white matter integrity, and cerebral blood flow perfusion, supporting exploratory analysis of the candidate mechanisms above. Safety is monitored throughout via adverse-event reporting, device-related event tracking, and review of skin and nasal tolerability. Efficacy analyses compare between- and within-group change from baseline across the cognitive, neuropsychiatric, sleep, daily-function, and caregiver-burden domains, with imaging and tolerability data used to characterize the safety profile and explore possible mechanisms of action of PBMT in AD-derived MCI and mild AD.
- Being tested
- Photobiomodulation
- Keywords
- Photobiomodulation, Transcranial photobiomodulation, Near-infrared light therapy, Alzheimer's disease, Mild cognitive impairment, Dementia;, Neuromodulation
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
transcranial photobiomodulation
PhotobiomodulationDevice
transcranial photobiomodulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6
Secondary outcomes (6)
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.
Measured: Baseline, Month 3, Month 6
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.
Measured: Baseline, Month 3, Month 6
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.
Measured: Baseline, Month 3, Month 6
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.
Measured: Baseline, Month 3, Month 6
Activities of Daily Living Scale
The 20-item Activities of Daily Living Scale (ADL-20) assesses basic and instrumental activities of daily living. Total scores range from 20 to 80; higher scores indicate greater dependence and worse functional ability, while lower scores indicate greater independence.
Measured: Baseline, Month 3, Month 6
Caregiver Burden Inventory
The Caregiver Burden Inventory (CBI) assesses time-dependence, developmental, physical, social, and emotional burden. Total scores range from 0 to 96; higher scores indicate greater caregiver burden and a worse outcome.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jinze Biotechnology Co. Ltd.
- Responsible party
- Sponsor-investigator, Jun Xu, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835399
- Sponsor's protocol ID
- JX-JZQ2024-07
- Acronym
- PBMT in MCI
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlines results in a publication