The FDA's Breakthrough Medical Device Program is designed to help patients gain more timely access to innovative technologies that can provide more effective treatment or diagnosis of life-threatening or irreversible debilitating diseases.
FDA will interact with Cognito on device development and clinical trial programs and will provide priority review of potential regulatory applications.
Alzheimer's disease is the most common neurodegenerative disease in the elderly, with considerable and far-reaching negative effects not only on the patients themselves, but also on their families, communities and society as a whole.
and since 2003, the FDA has not approved any innovative treatments for Alzheimer's disease.
that there are significant unseeded medical needs in this area.
digital therapy developed by Cognito Therapeutics is based on ground-breaking research by its co-founders, Edward S. Boyden and Dr. Li-Huei Tsai of the Massachusetts Institute of Technology.
, published in Nature in 2016, showed abnormalities in Gamma nerve oscillations in the brains of mice with Alzheimer's disease.
Gamma nerve oscillation is a kind of intra-brain neuron synchronization activity with frequency range of 30 to 100 Hz, and the neural network composed of inhibitory intermediate neurons is the main generator that produces this high-frequency rhythmic activity.
and more importantly, the researchers found that adjusting the gamma nerve oscillations of animals with specific sound and light stimuli could help promote the transformation of small glial cells in the brain into a phagocytosis pattern and help eliminate amyloid deposits in the brain.
Brent Vaughan, CEO of Cognito Therapeutics, said,
We are pleased that the product that treats Alzheimer's disease has been recognized by the FDA, based on the encouraging results achieved so far in several clinical studies.
this marks an important milestone for Cognito Therapeutics.
a new generation of digital therapies with drug-like mechanisms that can change the progress of disease.
look forward to working with the FDA to develop products for millions of people with neurodegenerative diseases.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
: s1. Cognito Therapeutics Receives FDA Product Device Designation for Next-Generation Digital Therapeutic in Alzheimer's Disease. Retrieved January 12, 2021, from  Iaccarino et al., (2016). Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature, doi:10.1038/nature20587.