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Mild Cognitive Impairment (MCI) Clinical Trial Recruitment (n=60)
Now Recruiting · Toronto
A clinical research study at St. Michael’s Hospital is recruiting adults aged 50 and over who have noticed recent memory changes. The study investigates photobiomodulation (PBM) via the Vielight Neuro, a non-invasive approach that uses gentle near-infrared (NIR) light, to learn whether it can support brain health in people with memory concerns. No formal diagnosis is required to ask about eligibility.
Interested in joining?
Phone: 416-360-4000 ext. 71725
Email: [email protected]
When you reach out, you can simply say: “I’m interested in the photobiomodulation memory study for people over 50.”
Why this study matters
Mild cognitive impairment (MCI) is a transitional stage between normal aging and Alzheimer’s dementia. Across long-term follow-up, research suggests that roughly a third of people with MCI progress to dementia, a majority remain stable, and a small share return to normal cognition at later visits. Existing medications can help manage symptoms for some people, but there remains a real need to study additional, non-invasive options that may support cognitive function with a favorable tolerability profile.
This study investigates PBM therapy: a non-invasive method that delivers gentle near-infrared light to the brain. Researchers want to understand whether this approach can support brain health in people who have begun to notice memory changes.
About the study at a glance
| Conducted by | University of Toronto and Unity Health Toronto, at St. Michael’s Hospital (Toronto) |
| Device studied | Vielight Neuro RX Gamma, a wearable headset (5 LEDs) plus an intranasal applicator (1 LED) |
| How it works | Delivers 810nm near-infrared light to targeted brain regions. It is non-thermal (produces no significant heat) and non-invasive (no surgery, no needles). |
| Design | Approximately 60 participants, randomized to an active or sham (placebo-like) device so outcomes can be compared fairly |
| At-home use | 20 minutes daily, 6 days a week, for 8 weeks |
| Follow-up | A return visit 4 weeks after the active phase to measure any lasting changes |
| Registry | ClinicalTrials.gov: NCT06618807 |
Important: PBM is being studied here to understand potential benefits. It is not an approved treatment for MCI, and participation is entirely voluntary.
Who can apply
You may be a good fit for the screening if you:
- Are 50 years or older
- Have noticed memory changes (for example, forgetfulness, difficulty finding words, or misplacing items), without a formal diagnosis of MCI or dementia
- Are able to undergo a blood test and an MRI scan (some MRI exceptions may be allowed)
If you are unsure whether you qualify, the study team can walk you through a brief screening to check eligibility.
What participation looks like
- Screening and consent. An initial assessment to determine whether you are eligible for the study.
- Baseline visit. Assessments of memory and thinking, a blood draw, and a brain MRI (MRI exceptions allowed).
- At-home use. 20 minutes daily, 6 days a week, for 8 weeks. The team will teach you exactly how to place and use the device.
- Check-ins. Short follow-ups to track how you are doing along the way.
- Post-study evaluation. Repeat assessments to measure any changes across the 8 weeks.
- Follow-up visit. Four weeks after the post-study evaluation, repeat memory assessments and a blood draw to measure lasting effects.
The LEDs are standard semiconductor light sources. There is no surgery and there are no needles involved in using the device.
Safety
In research settings, low-level PBM is generally considered safe and well-tolerated. As with any study, you will be informed of potential risks before you take part, and you can withdraw at any time.
Quick FAQ
Is this a treatment?
No. This is a clinical research study evaluating PBM. It is not an established treatment for MCI.
Do I need a diagnosis first?
No. If you are over 50 and noticing memory changes but do not have a formal diagnosis, you are welcome to contact the team for screening.
Will I definitely get the active device?
Not necessarily. To keep the results fair, some participants use a sham device. Where applicable, you will learn which one you had after the study.
Can I keep my current medications?
Please tell the study team about any medications you take. They will advise you on eligibility and any adjustments that may be needed.
Share with a friend or family member
If you know someone aged 50 or over who has been forgetting appointments, repeating questions, or feeling more “foggy” than usual, please share this post. Early participation in research can help advance options for everyone.
This post is for recruitment and general information only and does not replace medical advice. Please speak with your healthcare provider about any concerns regarding your memory or thinking.
Vielight devices are general wellness products. They are not intended to diagnose, treat, cure, or prevent any disease, including mild cognitive impairment, Alzheimer’s disease, or other forms of dementia.