Cognito Therapeutics is a digital therapeutics startup that specializes in discovering and developing treatments for neurodegenerative diseases, including Alzheimer’s disease (AD), using its proprietary neuromodulation platform.
The company's lead product, Spectris, is a proprietary wearable device that delivers gamma frequency light and sound stimulation to evoke gamma wave activity in the brain. This technology aims to slow the progression of AD by preserving brain structure, cognition, and function. Spectris received FDA Breakthrough Device Designation for the treatment of cognitive and functional symptoms associated with AD.
As of September 2024, Cognito Therapeutics was conducting a pivotal clinical trial to evaluate the efficacy and safety of Spectris as a potential disease-modifying therapy for AD. As of January 2024, over 240 patients were enrolled across 60 active sites in the US. The company expected to complete the trial and submit data to the FDA for review by the end of 2025.
Key customers and partnerships
The company partnered with Aetion, a real-world evidence technology and analytics provider, to create a predictive model to identify individuals at risk of AD and mild cognitive impairment so that they could benefit from early treatment. This model would also help to speed up the clinical development of Cognito’s late-stage clinical program.
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