Cognito Therapeutics
Cognito Therapeutics develops non-invasive therapeutics aimed at improving the lives of patients with neurodegenerative diseases, including a treatment for Alzheimer's that has received FDA Breakthrough Device Designation.
Overview of Cognito Therapeutics
Cognito Therapeutics focuses on developing novel therapeutics aimed at improving the lives of patients with neurodegenerative diseases. The company's treatment has received FDA Breakthrough Device Designation specifically for addressing cognitive and functional symptoms associated with Alzheimer’s disease. Cognito Therapeutics utilizes non-invasive methods to deliver proprietary visual and auditory stimulation to patients.
FDA Breakthrough Device Designation
Cognito Therapeutics has achieved FDA Breakthrough Device Designation for its treatment targeting cognitive and functional symptoms in Alzheimer’s disease. This designation is meant to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening diseases or conditions.
Phase 2 Clinical Trial Results
The company has successfully completed Phase 2 clinical trials, demonstrating significant results. The trials showed a 69% slowing of brain volume loss and a 77% slowing of functional decline in participants. These promising results support the potential efficacy of Cognito Therapeutics' treatment in slowing the progression of neurodegenerative diseases.
Non-Invasive Therapeutic Intervention
Cognito Therapeutics' treatment involves a non-invasive therapeutic intervention designed to preserve brain structure and function. The therapy delivers visual and auditory stimulation to evoke gamma wave activity in the brain. The treatment is provided through a wearable device that patients use for an hour each day in their homes, offering convenience and accessibility.
Clinical Studies and Patient Safety
Cognito Therapeutics' treatments have been tested across multiple clinical studies, with over 40,000 treatment sessions completed. Importantly, these studies reported no serious treatment-limiting adverse events, indicating a strong safety profile. The light and sound intensity of the treatments are personalized for each patient based on their EEG-evaluated tolerability and response.