MCIEarly Phase 1NCT05563298
Neuro RX Gamma for Amnestic Mild Cognitive Impairment (aMCI)
A Early Phase 1 study testing Neuro RX Gamma device in people with MCI and Amnestic Mild Cognitive Disorder, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Over 50 million people worldwide are currently living with dementia-a number projected to rise to 152 million by 2050. Mitochondrial dysfunction in the brains of individuals with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) has gained increasing attention as a potential mechanism and therapeutic… Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- MCI, Amnestic Mild Cognitive Disorder
- What is being tested?
- Neuro RX Gamma device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2023to 3 Feb 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, light sensitivity or Lyme disease.
Show all 18Show fewer
- Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
- Participant or caregiver 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.
- 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 light therapy treatment.
- Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma for the Treatment of Amnestic Mild Cognitive Impairment (aMCI)
Over 50 million people worldwide are currently living with dementia-a number projected to rise to 152 million by 2050. Mitochondrial dysfunction in the brains of individuals with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) has gained increasing attention as a potential mechanism and therapeutic target. However, no effective treatment specifically targeting mitochondrial function is currently available.
Photobiomodulation (PBM) is an innovative, non-invasive technique that delivers near-infrared light transcranially to the brain. PBM is believed to enhance mitochondrial function-particularly in tissues with high mitochondrial density such as the brain-by reducing oxidative stress and increasing ATP production. It can be safely administered to awake outpatients and does not require general anesthesia or surgical intervention. While preclinical and case studies suggest PBM may be beneficial in AD, the absence of placebo-controlled trials and objective biomarkers has limited understanding of its effectiveness and underlying mechanisms.
Read more
Objectives: This pilot feasibility study aims to assess cognitive outcomes and neural correlates associated with PBM in individuals with early amnestic MCI (aMCI). Participants who meet eligibility criteria (n = 20) will undergo a 6-week, home-based PBM intervention using the Neuro Rx Gamma device (6 days/week, 20 minutes/session). Clinical and cognitive assessments, blood sample collection, and structural and resting-state functional MRI scans will be conducted at two time points: baseline and post-treatment. These assessments will enable evaluation of PBM's effects on cognition and brain function, with particular focus on mitochondrial-related mechanisms.
This study offers a unique opportunity to investigate whether PBM can modulate mitochondrial and neural processes associated with cognitive decline in aMCI.
Read the detailed description
Intervention:
The experimental intervention will be the Vielight Neuro RX Gamma photobiomodulation (PBM) device, which delivers near-infrared light via five light-emitting diodes (LEDs) operating at a wavelength of 810 nm. The LEDs are positioned equidistantly on the scalp and intranasally to target key brain regions. The device generates no significant heat, enabling the use of an indistinguishable sham device for placebo control.
All participants will self-administer 20-minute sessions once daily, six days per week, for six weeks. Subjects and/or caregivers will receive training to ensure proper at-home use and will be asked to maintain a treatment diary to monitor adherence.
Assessments:
Each participant will undergo two in-person visits-at baseline (T0) and post-intervention (week 7; T2)-to complete the following evaluations:
Mini-Mental State Examination (MMSE) California Verbal Learning Test - Long Delayed Free Recall (CVLT-LDFR) Trail Making Test A and B (TMT-A, TMT-B)
Pittsburgh Sleep Quality Index (PSQI) Mild Behavioral Impairment Checklist (MBI-C) Blood tests: lactate and lactate-to-pyruvate (L/P) ratio Structural and resting-state functional MRI, 1H-MRS, CBF An additional safety check will be conducted at week 1, 3, 5, and at the end of the study (either remotely or in person).
Safety Endpoints:
Serious adverse events (SAEs), regardless of device causality Device-related adverse events (AEs) Rates of epistaxis (nosebleeds) and nasal infections
- Conditions
- MCI, Amnestic Mild Cognitive Disorder
- Being tested
- Neuro RX Gamma device, Sham Neuro RX Gamma device
- Keywords
- MCI, Photobiomodulation, PBM, AD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro RX Gamma deviceDevice
The Neuro RX Gamma device is a portable, wearable, low level light therapy (LLLT) delivery device. The Vielight Neuro RX Gamma delivers a synchronized pulse frequency of 40 Hz from all LED clusters.
Sham Neuro RX Gamma deviceDevice
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.
| Study group | Role | What they receive |
|---|---|---|
| Active Neuro Rx Device | Active comparator | The active device will deliver light for the 20 minutes session duration. Receives: Device: Neuro RX Gamma device |
| Sham Neuro Rx Device | Sham comparator | The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration. Receives: Device: Sham Neuro RX Gamma device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
MMSE is a brief 30-point assessment
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on verbal learning and memory assessed by California Verbal Learning Test-II (CVLT-II)
The Composite Score was created by grouping variables into domains and averaging the domains into a single Composite Score for each participant using:
CVLT-II - Total Recall Trials 1-5 CVLT-II - d' Hits and False Alarms of recognition Yes/No responses CVLT-II - Percent retained at long delay trial from trial 5 at immediate recall condition
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on processing speed assessed by Trail Making Test (TMT)-part A & B
Trail Making A - Time per correct connection
Measured: Assessed at baseline and post-intervention (week 7)
Secondary outcomes (9)
Changes from pre- to post-treatment on peripheral blood-biomarkers assessed by blood
Blood lactate and lactate/pyruvate ratio will be measured due to their noted relationship with mitochondrial function.
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on plasma biomarkers
markers of neuroinflammation (IL-6, IL-10), neurodegeneration (GFAP, NfL), tau pathology (phosphorylated Tau-217), and synaptic plasticity (Brain-Derived Neurotrophic Factor-BDNF)
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on Neuropsychiatric symptoms (NPS) using MBI-C (Mild Behavioral Impairment Checklist)
The MBI-C is a 34-item instrument and serves as a global and domain-specific NPS measure including early symptom presentations
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on structural MRI (T1-weighted imaging)
Cortical thickness and subcortical volume
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on brain metabolites (PCC)
N-acetylaspartate/creatine, lactate/creatine via single-voxel ¹H-MRS
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on structural MRI (Diffusion tensor imaging - DTI)
fractional anisotropy (FA), and mean diffusivity (MD) measure
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on resting state functional connectivity of the default mode network (DMN) via rs-fMRI
Brain networks functional connectivity
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on Pittsburgh sleep quality index
The measure consists of 19 individual items, creating 7 components that produce one global score
Measured: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on cerebral blood flow (CBF)
CBF using pseudo-continuous arterial spin labeling (PCASL) -with a focus on DMN
Measured: Assessed at baseline and post-intervention (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start28 Mar 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single-blind trial. The trial will include patients with amnestic MCI who will be randomized in a 1:1 ratio to treatment with an active or sham Neuro RX Gamma device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corinne Fischer, University of Toronto
- Investigators
- Corinne Fischer, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563298
- Sponsor's protocol ID
- REB 22-128
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 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 Vielight Neuro RX Gamma for the Treatment of Amnestic Mild Cognitive Impairment (aMCI)
- ClinicalTrials.gov ID
- NCT05563298
- Acronym / sponsor ID
- REB 22-128
- Conditions
- MCI, Amnestic Mild Cognitive Disorder
- Keywords
- MCI, Photobiomodulation, PBM, AD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 3 Oct 2022 (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.
Over 50 million people worldwide are currently living with dementia-a number projected to rise to 152 million by 2050. Mitochondrial dysfunction in the brains of individuals with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) has gained increasing attention as a potential mechanism and therapeutic target. However, no effective treatment specifically targeting mitochondrial function is currently available.
Photobiomodulation (PBM) is an innovative, non-invasive technique that delivers near-infrared light transcranially to the brain. PBM is believed to enhance mitochondrial function-particularly in tissues with high mitochondrial density such as the brain-by reducing oxidative stress and increasing ATP production. It can be safely administered to awake outpatients and does not require general anesthesia or surgical intervention. While preclinical and case studies suggest PBM may be beneficial in AD, the absence of placebo-controlled trials and objective biomarkers has limited understanding of its effectiveness and underlying mechanisms.
Objectives: This pilot feasibility study aims to assess cognitive outcomes and neural correlates associated with PBM in individuals with early amnestic MCI (aMCI). Participants who meet eligibility criteria (n = 20) will undergo a 6-week, home-based PBM intervention using the Neuro Rx Gamma device (6 days/week, 20 minutes/session). Clinical and cognitive assessments, blood sample collection, and structural and resting-state functional MRI scans will be conducted at two time points: baseline and post-treatment. These assessments will enable evaluation of PBM's effects on cognition and brain function, with particular focus on mitochondrial-related mechanisms.
This study offers a unique opportunity to investigate whether PBM can modulate mitochondrial and neural processes associated with cognitive decline in aMCI.
Detailed description
Intervention:
The experimental intervention will be the Vielight Neuro RX Gamma photobiomodulation (PBM) device, which delivers near-infrared light via five light-emitting diodes (LEDs) operating at a wavelength of 810 nm. The LEDs are positioned equidistantly on the scalp and intranasally to target key brain regions. The device generates no significant heat, enabling the use of an indistinguishable sham device for placebo control.
All participants will self-administer 20-minute sessions once daily, six days per week, for six weeks. Subjects and/or caregivers will receive training to ensure proper at-home use and will be asked to maintain a treatment diary to monitor adherence.
Assessments:
Each participant will undergo two in-person visits-at baseline (T0) and post-intervention (week 7; T2)-to complete the following evaluations:
Mini-Mental State Examination (MMSE) California Verbal Learning Test - Long Delayed Free Recall (CVLT-LDFR) Trail Making Test A and B (TMT-A, TMT-B)
Pittsburgh Sleep Quality Index (PSQI) Mild Behavioral Impairment Checklist (MBI-C) Blood tests: lactate and lactate-to-pyruvate (L/P) ratio Structural and resting-state functional MRI, 1H-MRS, CBF An additional safety check will be conducted at week 1, 3, 5, and at the end of the study (either remotely or in person).
Safety Endpoints:
Serious adverse events (SAEs), regardless of device causality Device-related adverse events (AEs) Rates of epistaxis (nosebleeds) and nasal infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind trial. The trial will include patients with amnestic MCI who will be randomized in a 1:1 ratio to treatment with an active or sham Neuro RX Gamma device.
| Arm | Type | Receives |
|---|---|---|
| Active Neuro Rx Device | Active comparator | Device: Neuro RX Gamma deviceThe active device will deliver light for the 20 minutes session duration. |
| Sham Neuro Rx Device | Sham comparator | Device: Sham Neuro RX Gamma deviceThe Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (18 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).
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 |
|---|---|---|
| Neuro RX Gamma deviceThe Neuro RX Gamma device is a portable, wearable, low level light therapy (LLLT) delivery device. The Vielight Neuro RX Gamma delivers a synchronized pulse frequency of 40 Hz from all LED clusters. | Device | Active Neuro Rx Device |
| Sham Neuro RX Gamma deviceThe Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration. | Device | Sham Neuro Rx Device |
Primary outcome
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
Time frame: Assessed at baseline and post-intervention (week 7)
MMSE is a brief 30-point assessment
Changes from pre- to post-treatment on verbal learning and memory assessed by California Verbal Learning Test-II (CVLT-II)
Time frame: Assessed at baseline and post-intervention (week 7)
The Composite Score was created by grouping variables into domains and averaging the domains into a single Composite Score for each participant using: CVLT-II - Total Recall Trials 1-5 CVLT-II - d' Hits and False Alarms of recognition Yes/No responses CVLT-II - Percent retained at long delay trial from trial 5 at immediate recall condition
Changes from pre- to post-treatment on processing speed assessed by Trail Making Test (TMT)-part A & B
Time frame: Assessed at baseline and post-intervention (week 7)
Trail Making A - Time per correct connection
9 secondary outcomes
Changes from pre- to post-treatment on peripheral blood-biomarkers assessed by blood
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on plasma biomarkers
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on Neuropsychiatric symptoms (NPS) using MBI-C (Mild Behavioral Impairment Checklist)
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on structural MRI (T1-weighted imaging)
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on brain metabolites (PCC)
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on structural MRI (Diffusion tensor imaging - DTI)
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on resting state functional connectivity of the default mode network (DMN) via rs-fMRI
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on Pittsburgh sleep quality index
Time frame: Assessed at baseline and post-intervention (week 7)
Changes from pre- to post-treatment on cerebral blood flow (CBF)
Time frame: Assessed at baseline and post-intervention (week 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Corinne Fischer, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neuro RX Gamma device in people with MCI and Amnestic Mild Cognitive Disorder, 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 5 inclusion and 18 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: finished, as of the sponsor's last update on 24 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE) (time frame: Assessed at baseline and post-intervention (week 7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.