Startup’s headset to treat Alzheimer’s will undergo wide trial with patients

Cognito Therapeutics became the latest company to secure a large-scale trial to treat Alzheimer’s disease. Unlike most other remedies in development today, this one involves a device rather than medicine.

The late-stage trial will enroll around 500 U.S. participants. They will wear a headset for an hour a day for a year. The headset will deliver light and sound at a frequency that, according to prior Cognito studies including one in the journal Neurology, delivers improved cognitive ability among people with Alzheimer’s.

Cognito, based in Cambridge, Massachusetts, will also show research about the effects of its device on the deterioration of the brain’s white matter, the intertwining neural connections that link all four lobes of the brain. Abnormalities in white matter, and the insulating layer that surrounds it called myelin, are associated with Alzheimer’s. “We’re quite optimistic,” said Cognito Chief Executive Officer Brent Vaughan.

Alzheimer’s is intractable. About 10 million people are diagnosed each year with the disease or other dementias, according to the World Health Organization. Many potential remedies over the years have initially shown promise and ultimately fallen short of expectations.

One highly anticipated drug, Eisai’s and Biogen’s lecanemab, has sparked excitement because it appears to reduce brain plaque associated with Alzheimer’s and could be approved by the U.S. Food and Drug Administration in early 2023. Shares of both companies rose after they released data about the drug. Still, lecanemab caused brain swelling and bleeding among 20% of those who took it in a trial, compared with 10% of the placebo group.

Cognito’s earlier trials were promising enough for the FDA to give the company breakthrough status, meaning a streamlined process for evaluation. Even if the Cognito headset proves effective in this latest trial, the earliest it could see wide adoption is 2024. It will take several months to enroll participants, then a year to collect the data and submit it for review.

Unlike other emerging therapies, Cognito seeks to preserve white matter in the brain rather than attack plaque buildup. Its device has drawbacks, including that it might be tough for some to devote an hour every day to wearing the headset. Some patients in earlier trials said they experienced ringing or buzzing in their ears when using it.

Some neurological conditions such as epilepsy have been shown to be treatable with devices. Most are invasive, involving implanted electrodes.

Cognito’s is noninvasive and resembles wrap-around sunglasses. It works using neuromodulation, meaning direct alteration of nerve activity by outside stimulus. The headset transmits lights and sounds at a frequency of 40 times per second. The light is more of a flicker than a flash, Vaughan said, and the sound a mild clicking or ticking, audible to the patient but not anyone else nearby. Patients can wear it at home rather than going to a clinic.

The device’s pulsing lights and sounds are aimed at stimulating immune cells called microglia in an effort to clear out proteins that can lead to disease and dementia.

Cognito has raised a total of $73 million from backers including FoundersX Ventures and Morningside Ventures. Its co-founders include Massachusetts Institute of Technology’s Ed Boyden, who has created a new approach to studying the brain through optogenetics, a way of turning key cells on and off with light. If Cognito’s treatment is proven, which is no guarantee, the device could one day have other applications. Mild cognitive impairment, some types of strokes and Parkinson’s disease are all conditions that could see benefits from stimulation, Vaughan said.