Cognito Therapeutics’ sensory stimulation device slowed the decline in daily functioning and cognitive abilities over six months compared to sham treatment in Alzheimer’s disease patients.

In new data shared from the Phase II OVERTURE I study (NCT03556280), Spectris AD provided 60%-84% more time where participants maintained their functional and cognitive abilities compared to sham treatment.

These time-saving observations suggest that study participants continued to live more independently and maintained their quality of life for a longer period. 

Spectris AD delivers flashing lights and sounds through a pair of connected glasses and headphones to stimulate gamma waves in the brain. Gamma waves are high-frequency brain waves linked with cognitive processes and memory, and people with Alzheimer’s are known to have fewer of them.

Brain waves result from neuron communication via electrical signals, and in Alzheimer’s, these connections deteriorate. The at-home device aims to slow cognitive decline by enhancing and synchronising these connections. 

The US-based company reported positive Phase II extension data in October 2023, where data collected over 18 months showed that the device reduces brain atrophy and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) decline, with no amyloid-related imaging abnormalities (ARIA) or treatment-limited serious adverse events.

OVERTURE I MRI analysis also demonstrated reduced corpus callosum atrophy over six months, suggesting that the device could have disease-modifying properties.

Cognito said that it will continue to evaluate these results in its HOPE trial (NCT05637801), which kicked off in January 2024. The randomised, double-blind, sham-controlled, adaptive-design trial aims to administer the therapy to 530 subjects with Alzheimer’s for 12 months.

If Cognito can secure US Food and Drug Administration (FDA) approval, the device could be used as a non-pharmacological alternative, or in conjunction with currently approved Alzheimer’s medications. Eli Lilly’s blockbuster Alzheimer’s drug Kisunla (donanemab) won FDA approval earlier this month, however, it runs the risk of infusion-related reactions and inducing ARIA. Cognito’s device has so far not shown any increased risk of ARIA in clinical trials.

Cognito’s chief medical officer Ralph Kern said: “This new post-hoc analysis from our OVERTURE I study highlights Spectris’ ability to significantly slow the decline in daily function and cognition in patients with Alzheimer’s, potentially offering patients more time to maintain their independence and quality of life.

“These results reinforce our commitment to bring a novel disease-modifying therapy to patients, as we continue to enrol patients in our HOPE pivotal trial.”

Cognito raised $35m in a January 2024 Series B funding round, building on a $73m Series B in March 2022.