Cognito Therapeutics and Providence Health Plan Launch Phase 3 Study to Evaluate Disease-Modifying Therapeutic in Mild Cognitive Impairment

Cognito Therapeutics and Providence Health Plan today announced a collaboration to conduct a Phase 3 study of Cognito’s breakthrough, non-invasive disease-modifying therapy for patients with Mild Cognitive Impairment (MCI).

Jan. 27, 2022 13:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Cognito Therapeutics and Providence Health Plan today announced a collaboration to conduct a Phase 3 study of Cognito’s breakthrough, non-invasive disease-modifying therapy for patients with Mild Cognitive Impairment (MCI).

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The Phase 3 real-world evidence study will evaluate the safety, efficacy, and cost-effectiveness of Cognito’s therapeutic platform in MCI patients treated within Providence Health Plan’s network of nationally renowned neurology specialists. This first of its kind registrational study is expected to begin in Q2 2022, running in parallel to Cognito’s pivotal Phase 3 study in patients with mild-to-moderate Alzheimer’s Disease (AD).

“Novel technologies, such as Cognito’s disease-modifying treatment are critical to improve patient outcomes in MCI,” said Dr. Nancy Isenberg, Medical Director, Center for Healthy Aging, Swedish Neuroscience Institute. “There are currently no drugs that have been approved for treating MCI, and patients need new safe, effective and affordable options.”

“We look forward to collaborating with Providence Health Plan on our Phase 3 programs evaluating our disease-modifying intervention across the full spectrum of patients from MCI to mild to moderate Alzheimer’s,” said Brent Vaughan, CEO, Cognito Therapeutics. “Our proprietary therapeutic platform holds the potential to create an entirely new approach to clinically meaningful improvements in patients across a broad range of conditions of neurodegeneration and neuropsychiatry.”

“Given our focus in MCI, Alzheimer’s, and other fatal neurodegenerative diseases we believe it is imperative to collaborate and partner with leading payor and provider organizations like Providence Health Plan to develop real-world, health economic, and clinical evidence across a diversity of populations,” said Dr. Tom Megerian, Chief Medical Officer, Cognito Therapeutics. “This allows us and our payor, provider, and patient partners to have the evidence and confidence to deploy and use our therapeutic platform across the millions of patients living with these devastating diseases.”

“There is a need for safe and cost-effective treatments in MCI and AD, to ensure that new treatments are rapidly adopted for use and access is provided to all patients who could benefit,” said Dr. Robert Gluckman, CMO of Providence Health Plan. “Approximately 12-18% of people aged 60 or older are living with MCI, and new therapies that can be deployed early in treatment to delay or halt disease progression are desperately needed.”

This newly launched study with Providence Health Plan is part of a larger multi-study Phase 3 program evaluating Cognito’s disease-modifying optogenetics-based therapeutic in patients with MCI and mild-to-moderate AD.

About Cognito Therapeutics

Cognito Therapeutics is a pioneer in disease-modifying therapeutic interventions for neurodegenerative diseases and human cognitive performance. The company has completed multiple clinical studies demonstrating its investigational therapeutic platform has the potential to safely slow or stop cognitive decline and loss of brain volume in Alzheimer’s disease. Cognito has received FDA Breakthrough Device Designation for the treatment of Alzheimer’s disease and expects to start pivotal studies in 2022. The company’s technology was based on pioneering optogenetics research by scientific co-founders Professors Li-Huei Tsai and Ed Boyden at MIT. Cognito Therapeutics is based in Cambridge, MA. For more information, please visit Follow us on Twitter at @cognitotx.

About Providence Health Plan

Providence Health Plan (PHP) is part of a 160-year-old not-for-profit integrated health care system that has set the health and well-being standard for the communities we serve. PHP provides high quality, affordable coverage to members via plans for small and large groups, self-insured plan sponsors, Medicare and Medicaid beneficiaries, as well as individuals and families. We offer a range of benefits including comprehensive health care, 24/7 access to telehealth visits, behavioral health resources and personalized health coaching.



Cognito Therapeutics
Kimberly Ha
KKH Advisors

Providence Health Plan
Erin McClellan

Source: Cognito Therapeutics