After demonstrating last year that its light- and sound-based therapy could help improve memory and cognition among Alzheimer’s patients in an early clinical study, Cognito Therapeutics is going a step deeper. It has new data showing that six months’ use of its digital therapeutic could potentially reduce the rate of atrophy within the brain's white matter.
Home to high concentrations of axons and their myelin sheaths, the white matter ferries electrical signals among the brain’s large regions of gray matter. Deteriorating white matter is a normal sign of aging, though the atrophy can be more pronounced in Alzheimer’s patients.
By using a headset that delivers pulsing lights and sounds at fast and specific frequencies, the Fierce 15 winner aims to stimulate the activity of immune cells inside the brain known as microglia. The aim is to help the central nervous system clear out certain proteins that can lead to different neurological diseases and dementia.
The company said it plans to launch new, pivotal trials this year in Alzheimer’s disease.
Cognito delivered the latest findings at the Alzheimer’s Association International Conference in San Diego. In the phase 2 study, named Overture, participants wore the company’s GammaSense headset at home for one hour per day for six months.
Cognito’s analysis compared participants treated in the Overture study, which enrolled 76 people, to historical data collected from a separate, decade-long, global study conducted by the Alzheimer’s Disease Neuroimaging Institute. The company said it saw less white matter shrinkage after half a year—even slightly increasing over baseline readings, by about 0.4% compared to the start of the Overture trial. ADNI participants, on the other hand, saw white matter volume decline by about 2% on average during the same amount of time. The ADNI study collected regular brain scans from 200 Alzheimer’s patients and 400 people diagnosed with mild cognitive impairment.
“These results continue to build on our knowledge and understanding of how gamma frequency patterns in the brain are disrupted in patients with Alzheimer’s disease, and how our technology restores the levels of neural activity to improve cognition,” Cognito CEO Brent Vaughan said in the press release announcing the new data.
In March 2021, the company released results from Overture showing slowdowns in the decline of memory and cognitive function, as well as in the physical ability to perform everyday activities.
Prior to that, Cognito’s GammaSense device received a breakthrough designation from the FDA—after demonstrating a reduction of amyloid plaques in mouse studies—granting the company priority review and additional opportunities to work with the agency during clinical development.
The device-based approach is also in the earlier stages of being studied in Parkinson’s disease and multiple sclerosis, as well as in damage from stroke and dementia related to traumatic brain injuries.