Yesterday Cognito Therapeutics, a startup using visual and auditory stimulation to treat neurodegenerative disorders, announced Phase 2 trial results suggesting its gamma frequency neuromodulation therapy slowed declines in memory and cognition among mild-to-moderate Alzheimer's disease patients.
The OVERTURE study, a multi-center, randomized controlled trial, enrolled 76 such patients aged 50 years or older beginning in 2018. These participants were randomized to receive either Cognito's audio-visual stimulation treatment or a sham stimulation for one hour each day in their home.
Throughout the six-month treatment period, Cognito said the treatment group (n = 33) compared to the placebo group (n =20) demonstrated a significant 84% slowdown in functional decline and a significant 83% decline in cognitive impairment, as measured using standardized scales every four weeks. In addition, there was a significant 61% reduction in whole brain atrophy and volumetric loss among 30 treatment group participants in comparison to 19 placebo group participants, according to the company.
"Our approach has translated into clinical proof of concept by successfully achieving statistically significant results in [Alzheimer's disease], with a potential for disease modification due to significant reduction of cerebral atrophy and volumetric loss," Dr. Tom Megerian, chief medical officer of Cognito Therapeutics, said in a statement. "In addition to improving functional outcomes, memory and cognition, the 61% reduction in loss of whole brain volume in our Phase 2 study addresses key aspects of [Alzheimer's disease] etiology and disease progression. If these results are replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer's research."
Outside of these top-line results, Cognito is reporting the study results this week at the 2021 AD/PD, a conference on Alzheimer's and Parkinson's diseases and related neurological disorders, and will be holding a virtual panel with executives and researchers on Friday regarding these and prior research data on the treatment.
WHAT'S THE IMPACT
Cognito's lead product is a device delivering flickering lights and other stimuli to induce gamma oscillations, a pattern of brain waves that research suggests is related to cognition. The startup licensed the technology from MIT researchers and cofounders Li-Huei Tsai and Ed Boyden, and in January of this year received a Breakthrough Device Designation from the FDA.
With these positive results, Cognito said it will now move forward with a large-scale pivotal clinical trial of the therapy and – should that effort pan out as well – the FDA approval process.
"With our recent FDA Breakthrough Device Designation, we look forward to expediting the clinical development of what has the promise to be the first disease-modifying digital therapeutic in Alzheimer's disease," CEO Brent Vaughan said in a statement.
THE LARGER TREND
Cognito – which brands itself as a digital therapeutic company – is joined in the Alzheimer's space by Neuroglee Therapeutics, a Singapore-based startup that raised $2.3 million in pre-seed funding in December to tackle neurodegenerative diseases with artificial intelligence, machine learning and digital biomarkers. Looking further back, Cognito's Breakthrough Device Designation was preceded by neurodegenerative digital therapeutics company Dthera Sciences, which gained the designation in 2018.
Alzheimer's and other neurodegenerative diseases have also been a focus for the broader digital health space. Sensors and software from wearables, apps and other tools have been used to spot early cases, leading Biogen and Apple to recently announce a new observational study on the subject.
