Laser Therapy for Mild Cognitive Impairment
(PBMCI-Prime Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for mild cognitive impairment (MCI), a condition affecting memory and thinking skills that can lead to Alzheimer's disease. The study tests a device called Neuro RX Gamma (v2), which uses a special type of light therapy to aid brain function. Participants will use either an active device or a sham (inactive) device at home for 8 weeks. Ideal candidates for this trial are individuals who have noticed cognitive issues, such as memory problems, but still manage daily tasks well. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research in cognitive health.
Do I have to stop taking my current medications for the trial?
If you are taking cholinesterase inhibitors or memantine, you must be on a stable dosage for at least the prior 3 months to participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What prior data suggests that the Neuro RX Gamma (v2) device is safe for treating mild cognitive impairment?
Research has shown that photobiomodulation (PBM) therapy, such as that used in the Neuro RX Gamma device, is generally safe and well-tolerated. Studies have found that PBM can enhance brain function without causing serious side effects. For instance, a small study found that using transcranial PBM (light therapy on the brain) with devices like the Neuro RX Gamma did not result in major negative effects.
Participants reported only mild and temporary side effects, if any, indicating that most people did not experience discomfort or harm during this therapy. The treatment involves shining a special light on the head, which aids in repairing and healing brain cells. It is non-invasive, meaning it doesn't involve surgery or entering the body, and it doesn't produce significant heat, making it safe.
Overall, PBM therapy is considered a promising option for individuals with mild cognitive impairment, with a good safety record based on studies conducted so far.12345Why are researchers excited about this trial?
Researchers are excited about Neuro RX Gamma (v2) for mild cognitive impairment because it uses a novel approach called transcranial photobiomodulation (tPBM). Unlike traditional treatments, which often rely on medications to manage symptoms, this device delivers light therapy directly to the brain, potentially enhancing brain function and plasticity. This non-invasive method is administered at home, offering convenience and eliminating the need for frequent clinic visits, which could make it more accessible for patients.
What evidence suggests that the Neuro RX Gamma (v2) device is effective for mild cognitive impairment?
Research has shown that transcranial photobiomodulation (tPBM), similar to the treatment provided by the Neuro RX Gamma device, may benefit people with mild cognitive impairment (MCI). In this trial, participants in the active group will receive tPBM using the active Neuro RX Gamma (v2) device. Early studies suggest that this treatment can enhance brain functions such as memory and thinking skills. It might also improve the connectivity between different brain regions and support cell health by enhancing mitochondrial function, which serves as the cell's energy producer. Although more research is needed, these initial findings indicate that tPBM could be a safe and effective way to manage MCI symptoms.12467
Are You a Good Fit for This Trial?
This trial is for individuals with mild cognitive impairment (MCI) or early Alzheimer's disease. Participants should be experiencing memory loss, confusion, and difficulty with thinking and reasoning. Those who have other serious medical conditions that could interfere with the study or are currently receiving certain treatments for MCI may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo an 8-week trial of home-use PBM using the Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cognitive assessments and blood-based biomarker tests
What Are the Treatments Tested in This Trial?
Interventions
- Neuro RX Gamma (v2)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor
The W. Garfield Weston Foundation
Collaborator
HILARY AND GALEN WESTON FOUNDATION
Collaborator