Cognito Therapeutics completes enrollment in landmark Alzheimer’s trial

Cognito Therapeutics' noninvasive Alzheimer's treatment device: ©Cognito Therapeutics

Cognito Therapeutics announced it has completed enrollment of 670 participants in the HOPE Study, a pivotal clinical trial evaluating the safety and efficacy of its investigational neuromodulation device, Spectris, for patients with Alzheimer’s disease.

According to the company, the HOPE Study (NCT05637801) is the largest medical device trial ever focused solely on Alzheimer’s disease. The randomized, double-blind, sham-controlled study spans 70 sites across the U.S. and includes a 12-month treatment phase followed by a 12-month open-label extension. Participants will use the device, which delivers synchronized light and sound stimulation at the 40Hz gamma frequency, in their homes daily.

“Completing enrollment in this landmark trial marks a major step forward in our mission to deliver a better treatment option for people living with neurodegenerative conditions, like Alzheimer’s,” said Christian Howell, CEO of Cognito Therapeutics. “We’re proud to lead one of the largest and most advanced device studies in the history of Alzheimer’s disease.”

The trial builds on promising results from the OVERTURE feasibility study, which showed a 76% reduction in cognitive decline, a 77% reduction in functional decline, and a 69% reduction in whole brain atrophy over six months. The HOPE Study aims to confirm these findings in a larger population, using changes in ADCS-ADL and MMSE scores as its primary endpoint.

“There is an urgent need for safe, effective, and scalable treatments for Alzheimer’s,” said Ralph Kern, chief medical officer at Cognito. “Our technology is non-invasive, has shown strong early signals in functional and structural outcomes, and may be uniquely suited to deliver a home-based therapy.”

The Spectris AD system remains investigational and is not currently available for commercial use.

Non-invasive innovations advance alzheimer’s treatment landscape

Alzheimer’s disease affects more than six million Americans and remains one of the most challenging neurodegenerative disorders to treat. While drug therapies have gained attention in recent years, non-invasive treatments—like neuromodulation and digital therapeutics—are rapidly emerging as complementary or alternative options.

Gamma-frequency stimulation, such as the 40Hz sensory stimulation used in Cognito’s device, is drawing interest after animal studies demonstrated that it may reduce amyloid plaques and improve cognitive performance. These findings have encouraged exploration of light and sound therapies in human trials, targeting brain wave entrainment to restore neuronal health.

In parallel, advancements in home-based monitoring and remote clinical trials are expanding access and convenience for Alzheimer’s patients and caregivers. Wearable EEGs, digital biomarkers, and mobile apps are enabling researchers to track disease progression with greater precision, without the burden of frequent clinic visits.

Non-invasive brain stimulation using technologies like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) is also being studied, although these approaches typically require in-clinic sessions. The promise of fully home-based systems like Spectris lies in their scalability and ability to integrate into daily life, reducing the burden on both patients and caregivers.

While no single approach is expected to reverse Alzheimer’s, the integration of non-pharmacologic therapies with traditional treatments may ultimately reshape how the disease is managed, offering hope for improved quality of life and slower decline.