In a sea of failed Alzheimer’s treatments, a digital health startup is hoping to find answers in a noninvasive treatment using light and sound.
Cognito was founded by MIT Professors Li-Huei Tsai and Ed Boyden. The company was spun out of research where they found they could reduce amyloid plaques in mice by exposing them to light flickering at a certain frequency. Now, they’re seeing if the treatment holds promise for Alzheimer’s patients.
Cognito shared results of a small, phase 2 clinical trial at the Alzheimer’s and Parkinson’s Diseases Conference on Friday, which resulted in improvements in memory, cognition, and a reduction in brain atrophy.
“We’re excited about the study,:” Cognito CEO Brent Vaughan said in a Zoom interview. “For us, the most exciting thing in Alzheimer’s — the holy grail — is to show disease modification. No one’s every gotten such a claim.”
Cognito is currently developing its device as a standalone treatment, though it could also be used in conjunction with medication. It received a Breakthrough Device Designation from the Food and Drug Administration in January based on those same results. If successful, it would be covered by Medicare after launch.
But getting there is still a long road ahead.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“I’ve worked at a company that took two drugs for Alzheimer’s through Phase 2 trials,” Vaughan said. “Alzheimer’s is hard.”
The randomized controlled trial tested the efficacy of gamma frequency light and sound over six months. Cognito enrolled 76 people over age 50 with mild-to-moderate Alzheimer’s disease. They also had imaging indicating the presence of beta-amyloid in the brain.
The participants either used Cognito’s system, or a sham simulation for one hour at home every day.
The flickering light, Vaughan said, is barely noticeable, and not uncomfortable. Participants wore eyewear and earphones, and were set up with an EEG. In fact, most of the patients who had the opportunity to continue in an open label extension of the study took it.
“When you turn on the device and start providing stimulation, you start to see oscillation show up in the EEG because you’re causing it,” Vaughan said. “The two regions start to fire by themselves in sequence with each other.”
The stimulation is also thought to activate an immune response, with microglial cells removing the characteristic amyloid beta and tau proteins.
The 30 participants in the treatment group had a 61% reduction in brain atrophy compared to the placebo group after six months. They also reported an 84% slowing of functional decline according to the ADCS-ADL score, which tests how patients perform in basic daily living activities. They also had 83% slowing in decline compared to the placebo, according to the Mini-Mental State Exam, a screening where participants must name the date, their location, remember three objects and other simple tests.
“We want to have a study that looks apples-to-apples to other drug studies, because that’s how we want our outcomes to be judged,” he said.
The results were promising, though more research is needed, given the small number of participants in the trial.
Based on these findings, Cognito plans to launch a large-scale pivotal study to submit to the FDA for approval. Vaughan said they hoped to start it in the second half of the year.
Photo credit: mrspopman, Getty Images
