Cognito Therapeutics has spent the better part of the last decade developing neuromodulation technology that it claims could stop and even reverse the progression of Alzheimer’s and other neurodegenerative diseases, and newly published study results suggest the tech is well on its way to reaching that goal.
Cognito published an analysis (PDF) of the MRI data collected in its phase 2 study, dubbed Overture, in the Journal of Alzheimer’s Disease this month. In the study, patients with Alzheimer’s were tasked with using Cognito’s neuromodulation headset for an hour each day for the entire six-month study period.
The headset delivers flashing, gamma-frequency light and sounds through a connected pair of glasses and headphones. The therapy is meant to stimulate gamma oscillations in the brain, with an aim of changing the pathology of proteins associated with neurodegenerative diseases—by encouraging the creation of stronger connections throughout the brain and activating immune cells.
The analysis of the Overture study data focused on patients’ white matter and myelin content, as the loss of both “may be a mechanistically important AD treatment target and may identify individuals at high risk of disease progression,” as Cognito CEO Brent Vaughan noted in a company release this week.
In comparing the participants’ MRI data from before and after the study, the researchers found that while those in the placebo group saw their total cerebral white matter volume decrease by an average of 2.54%, those who used Cognito’s device for six months actually saw their white matter increase, by an average of 0.17%—a statistically significant difference, per the researchers.
There was also a statistically significant improvement in myelin content, though both groups showed decreases on that front. The sham group’s myelin content fell by nearly 6.2%, while the active treatment group kept the decrease to an average of 1.42%.
And the improvements were particularly pronounced in the entorhinal region of the brain, where the Cognito users saw white matter increase by more than 5%, compared to a 7.6% volume loss for the placebo participants.
Because that region is linked to learning and memory, the results “may have significant implications for early AD intervention, considering the crucial afferent connections to the hippocampus and entorhinal cortex,” Ralph Kern, M.D., Cognito’s chief medical officer, said in the release.
The former Fierce 15 honoree is already recruiting for its next study of the technology, a phase 3 pivotal trial dubbed the Hope trial. That study is expected to wrap up in the first half of 2025, according to the federal clinical trials database, and its results will ideally be used to support Cognito’s submission to the FDA.
Cognito already has its foot in the door with the agency, as it earned a breakthrough device designation for its technology in early 2021.