Mild Cognitive Impairment (MCI) Due to Alzheimer's DiseasePBMCI-PrimeNCT06618807
Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
A study testing Active tPBM device in people with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- What is being tested?
- Active tPBM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who meet the criteria for MCI of 1) cognitive concern by the subject, informant, or clinician; 2) Montreal Cognitive Assessment (MoCA) score between 19-25 and impairment in learning and memory domain; 3) essentially normal functional activities as derived from the Clinical Dementia Rating Scale (CDR) and 4) the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease. , Age is greater than or equal to 50 years old. Meets the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease.
- Essentially normal functional activities as derived from the CDR. If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months.
- MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.
Who cannot join
- Cannot tolerate blood draws. Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners.
- A pace-maker or other metal implants that would preclude safe use of MRI. DSM 5 diagnosis of alcohol or other substance use disorders within the past 12 months.
- Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
- Any history of stroke, seizures, MS, or Lyme disease. Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
- Participant does not speak English at a level necessary for the completion of the assessments.
- Has not completed at least a grade eight education, as necessary for the completion of the assessments.
Show all 11Show fewer
- Currently participating in another clinical research study involving an investigational product.
- History of significant agitation and/or aggression, epileptic seizures. Current neurologic disease affecting cognition other than Alzheimer's disease. Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity).
- History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin) Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month.
- Pregnant or lactating or planning to become pregnant. Currently undergoing infrared light therapy treatment. Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.
- Note: Participants with contraindications for MRI can still enroll in the trial and participate without undergoing the MRI procedure. However, if participants do not have contraindications, undergoing the MRI is required as part of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M5B 1T8
Neda Rashidi, Manager of Research Program, MD, PhD, 416-360-4000 ext. 47838, neda.rashidi-ranjbar@unityhealth.to
Negah Rad, Research Assistant, 416-360-4000 ext. 47838, Negah.SadighiRad@unityhealth.to
About this study
Official title: A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Neuro RX Gamma (Version 2) for the Treatment of Mild Cognitive Impairment (MCI)
Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits.
Current treatment for MCI includes cholinesterase inhibitors (donepezil, galantamine and rivastigmine), and NMDA receptor antagonists (memantine) which delay or slow the worsening of symptoms and treat cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning). Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments, there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects.
Photobiomodulation (PBM) therapy also called low-level laser (or light) therapy (LLLT) is a safe, non-invasive, non-thermal (no significant heat is generated) method of therapy which uses either visible red or near-infrared (NIR) light to stimulate, heal and repair damaged or dying tissue cells. This study proposes to use the Neuro RX Gamma device (version 2) to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants.
Read the detailed description
This study will recruit approximately 60 participants with MCI for the study, and the total expected duration of the participant's participation in the study is 12 weeks. The active and sham Neuro RX gamma device (v2) consists of a headset with a built-in controller and nasal applicator. The nasal applicator contains a single LED and will be placed into the nostril and clipped into place. The headset is a wearable applicator that may be adjusted. It consists of 5 LEDs. A red star symbol identifies the front of the headset and helps the user orientate the headset on the head. LEDs are semiconductor electronic components that emit light.
- Being tested
- Active tPBM device, Sham device
- Keywords
- photobiomodulation, light therapy, Alzheimer's Disease, clinical trial, Mild Cognitive Impairment (MCI), home-based treatment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tPBM deviceDevice
The Neuro RX Gamma (version 2) delivers a synchronized pulse frequency of 40 Hz from all LED clusters. The gamma pulse frequency of 40 Hz has been demonstrated to attenuate amyloid beta proteins production in the hippocampus and modulate microglial activity resulting in increased scavenging of amyloid beta which may lead to improving cognition in MCI. Finally, the Vielight Neuro RX Gamma (version 2) has been designed to target the delivery of NIR energy to particular brain regions; specifically the default mode network (DMN). The active intervention device proceeds to deliver light to each LED at 40 Hz with a 50% duty cycle for 20 minutes and stops automatically. During the 20 minute treatment the power indicator LED on the controller flashes green at 40 Hz. The operator is notified that the treatment is finished when the power indicator LED on the controller stops flashing and the device beeps 2 times.
Sham deviceDevice
The sham device delivers infrared light for only a few seconds before stopping. The controller will still show a green light to maintain the study\'s blinding. If the headset is removed, the device will emit a beep and cease functioning.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The active group will undergo a 8-week trial of home-use tPBM using the active Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session. Receives: Device: Active tPBM device |
| Sham group | Sham comparator | The sham group will undergo a 8-week trial of home-use PBM using the sham Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Montreal Cognitive Assessment (MoCA)
Measured: Change from pre- to post-treatment (week 0, week 9)
Secondary outcomes (2)
Blood biomarkers
peripheral blood lactate and lactate/pyruvate ratio (blood draw)
Measured: Change from pre- to post-treatment (week 0, week 9)
Imaging biomarker
Proton magnetic resonance spectroscopy (H-MRS) for brain metabolites
Measured: Change from pre- to post-treatment (week 0, week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Jan 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI) Due to Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- The trial is a randomized, double-blind, sham-controlled trial designed to evaluate the efficacy of transcranial photobiomodulation (tPBM) in improving cognitive function among patients with MCI. Participants will be randomly assigned in a 1:1 ratio to receive either active tPBM treatment or a sham treatment. The trial will evaluate the effects of home-based tPBM sessions daily 6 days/week over 8 weeks on mitochondrial function via Blood-based and Neuroimaging biomarkers in patients with MCI.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinne Fischer, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618807
- Sponsor's protocol ID
- REB #24-188
- Acronym
- PBMCI-Prime
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papi S, Allahverdipour H, Jahan A, Dianat I, Jafarabadi MA, Salimi MM. The effect of transcranial photobiomodulation on cognitive function and attentional performance of older women with mild cognitive impairment: a randomized controlled trial. Prz Menopauzalny. 2022 Sep;21(3):157-164. doi: 10.5114/pm.2022.119794. Epub 2022 Sep 28.
PubMed 36254133Cheung MC, Lee TL, Sze SL, Chan AS. Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. Front Psychol. 2023 Jan 10;13:1095111. doi: 10.3389/fpsyg.2022.1095111. eCollection 2022.
PubMed 36704674
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Neuro RX Gamma (Version 2) for the Treatment of Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT06618807
- Acronym / sponsor ID
- PBMCI-Prime / REB #24-188
- Keywords
- photobiomodulation, light therapy, Alzheimer's Disease, clinical trial, Mild Cognitive Impairment (MCI), home-based treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild cognitive impairment (MCI) is a transitional risk state that occurs between the normal aging process and Alzheimer's dementia (AD). On average 32% of patients with MCI will progress to dementia, 62% will stay stable, and about 6% will return to normal cognition at subsequent visits.
Current treatment for MCI includes cholinesterase inhibitors (donepezil, galantamine and rivastigmine), and NMDA receptor antagonists (memantine) which delay or slow the worsening of symptoms and treat cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning). Despite currently ongoing drug studies and modest clinical benefits of currently approved drug treatments, there continues to remain a need for treatments for long term symptomatic improvement of MCI with fewer and less severe side effects.
Photobiomodulation (PBM) therapy also called low-level laser (or light) therapy (LLLT) is a safe, non-invasive, non-thermal (no significant heat is generated) method of therapy which uses either visible red or near-infrared (NIR) light to stimulate, heal and repair damaged or dying tissue cells. This study proposes to use the Neuro RX Gamma device (version 2) to deliver NIR light energy to particular brain regions which are dysfunctional in MCI participants.
Detailed description
This study will recruit approximately 60 participants with MCI for the study, and the total expected duration of the participant's participation in the study is 12 weeks. The active and sham Neuro RX gamma device (v2) consists of a headset with a built-in controller and nasal applicator. The nasal applicator contains a single LED and will be placed into the nostril and clipped into place. The headset is a wearable applicator that may be adjusted. It consists of 5 LEDs. A red star symbol identifies the front of the headset and helps the user orientate the headset on the head. LEDs are semiconductor electronic components that emit light.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial is a randomized, double-blind, sham-controlled trial designed to evaluate the efficacy of transcranial photobiomodulation (tPBM) in improving cognitive function among patients with MCI. Participants will be randomly assigned in a 1:1 ratio to receive either active tPBM treatment or a sham treatment. The trial will evaluate the effects of home-based tPBM sessions daily 6 days/week over 8 weeks on mitochondrial function via Blood-based and Neuroimaging biomarkers in patients with MCI.
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: Active tPBM deviceThe active group will undergo a 8-week trial of home-use tPBM using the active Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session. |
| Sham group | Sham comparator | Device: Sham deviceThe sham group will undergo a 8-week trial of home-use PBM using the sham Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals who meet the criteria for MCI of 1) cognitive concern by the subject, informant, or clinician; 2) Montreal Cognitive Assessment (MoCA) score between 19-25 and impairment in learning and memory domain; 3) essentially normal functional activities as derived from the Clinical Dementia Rating Scale (CDR) and 4) the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease. , Age is greater than or equal to 50 years old. Meets the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease.
- Essentially normal functional activities as derived from the CDR. If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months.
- MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.
Key exclusion criteria (11 listed)
- Cannot tolerate blood draws. Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners.
- A pace-maker or other metal implants that would preclude safe use of MRI. DSM 5 diagnosis of alcohol or other substance use disorders within the past 12 months.
- Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
- Any history of stroke, seizures, MS, or Lyme disease. Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
- Participant does not speak English at a level necessary for the completion of the assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tPBM deviceThe Neuro RX Gamma (version 2) delivers a synchronized pulse frequency of 40 Hz from all LED clusters. The gamma pulse frequency of 40 Hz has been demonstrated to attenuate amyloid beta proteins production in the hippocampus and modulate microglial activity resulting in increased scavenging of amyloid beta which may lead to improving cognition in MCI. Finally, the Vielight Neuro RX Gamma (version 2) has been designed to target the delivery of NIR energy to particular brain regions; specifically the default mode network (DMN). The active intervention device proceeds to deliver light to each LED at 40 Hz with a 50% duty cycle for 20 minutes and stops automatically. During the 20 minute treatment the power indicator LED on the controller flashes green at 40 Hz. The operator is notified that the treatment is finished when the power indicator LED on the controller stops flashing and the device beeps 2 times. | Device | Active group |
| Sham deviceThe sham device delivers infrared light for only a few seconds before stopping. The controller will still show a green light to maintain the study\'s blinding. If the headset is removed, the device will emit a beep and cease functioning. | Device | Sham group |
Primary outcome
Cognition
Time frame: Change from pre- to post-treatment (week 0, week 9)
Montreal Cognitive Assessment (MoCA)
2 secondary outcomes
Blood biomarkers
Time frame: Change from pre- to post-treatment (week 0, week 9)
Imaging biomarker
Time frame: Change from pre- to post-treatment (week 0, week 9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 36254133Papi S, Allahverdipour H, Jahan A, Dianat I, Jafarabadi MA, Salimi MM. The effect of transcranial photobiomodulation on cognitive function and attentional performance of older women with mild cognitive impairment: a randomized controlled trial. Prz Menopauzalny. 2022 Sep;21(3):157-164. doi: 10.5114/pm.2022.119794. Epub 2022 Sep 28.
- Background: PubMed 36704674Cheung MC, Lee TL, Sze SL, Chan AS. Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. Front Psychol. 2023 Jan 10;13:1095111. doi: 10.3389/fpsyg.2022.1095111. eCollection 2022.
- Results of the pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Not yet recruiting
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic
Recruiting
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Recruiting
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
Alzheimer's Disease
Not yet recruitingObservational study
A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease
Alzheimers Disease
Recruiting
The Effect of Urolithin A (Mitopure®) on Alzheimer's Disease
Alzheimer's Disease (AD), Early Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tPBM device in people with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Fischer, MD, FRCP(C) (416-360-4000 ext. 47838, Corinne.Fischer@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Change from pre- to post-treatment (week 0, week 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618807, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.