Infrared Light for Memory Loss in Mild Cognitive Impairment (MCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Active tPBM device
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.
Sham device
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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active groupActive comparator 1 intervention
Group B: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognition
Montreal Cognitive Assessment (MoCA)
Time frame
Change from pre- to post-treatment (week 0, week 9)Secondary outcomes
1
Blood biomarkers
peripheral blood lactate and lactate/pyruvate ratio (blood draw)
Time frame
Change from pre- to post-treatment (week 0, week 9)2
Imaging biomarker
Proton magnetic resonance spectroscopy (H-MRS) for brain metabolites
Time frame
Change from pre- to post-treatment (week 0, week 9)Other outcomes
1
Follow up cognition
Montreal Cognitive Assessment (MoCA)
Time frame
Week 13 - Four weeks after the post-treatment assessments2
Follow up blood-based biomarker
Blood test (lactate/pyruvate)
Time frame
Week 13 - Four weeks after the post-treatment assessmentsSponsors and contacts
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Source ClinicalTrials.gov