Investigating Quantitative EEG as Biomarker of Patient Response to Treatment in Future Efficacy Studies
PITTSBURGH, July 09, 2019 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on the protection and restoration of synaptic function in Alzheimer’s disease and other neurodegenerative disorders, today announced the receipt of a grant expected to total $3.3 million from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), to conduct a clinical trial (COG0202) in which quantitative electroencephalography (qEEG) will be used to measure changes in synaptic activity in individuals with Alzheimer’s disease who have been treated with Cognition’s lead candidate, Elayta™.
This pilot study, which is expected to commence in the second half of 2019, will be conducted under the direction of Philip Scheltens, M.D., Ph.D., professor of cognitive neurology at Amsterdam University Medical Centers and director of the Alzheimer Center Amsterdam, The Netherlands. Dr. Scheltens is a world leader in the development of biomarkers and imaging techniques for Alzheimer’s disease detection and diagnosis.
“This new study will investigate whether Elayta’s displacement of Aβ oligomers, a protein which is highly toxic to synapses, results in changes to Alzheimer’s-specific abnormalities in the brain’s electrical activity that are detectable by qEEG,” explained Professor Scheltens. “Measuring a difference between Alzheimer’s patients treated with Elayta and placebo would provide important evidence of the drug’s ability to protect synaptic function. Moreover, such a finding would have enormous impact on the larger field of neurology, as it would provide support for qEEG as a noninvasive biomarker of Alzheimer’s treatment effect.”
“We are delighted to initiate this relationship with Dr. Scheltens and his colleagues, who are world experts in qEEG analyses, and to receive the further support of the NIA.” stated Anthony O. Caggiano, M.D., Ph.D., Cognition’s chief medical officer. “We look forward to working together on this innovative approach to assess our first-in-class candidate and the potential of qEEG as a biomarker of treatment effect.”
“In previous clinical studies, Elayta has demonstrated significant reduction of synaptic damage proteins in the CSF following 28 days of administration,” said Susan Catalano, Ph.D., Cognition’s chief science officer and principle investigator of the awarded NIA grant. “EEG can sensitively and quantitatively measure rapid changes in brain synaptic activity that are impacted as Alzheimer’s disease progresses, which will allow us to directly test the mechanism of action of Elayta noninvasively.”
Elayta is a highly brain penetrant small molecule drug that has been shown to displace Aβ oligomers from their synaptic receptor binding sites. Elayta protects against further oligomer binding, stopping the synapse damage and loss characteristic of neurodegenerative diseases such as Alzheimer’s.
COG0202 is funded by a $3.3 million grant from the NIA under award number AG058710. Elayta is also being studied in three Phase 2 clinical studies: SPARC, SNAP and SHINE, which are supported by a combined $23.2 million from the NIA.
Kenneth I. Moch, Cognition’s president and CEO concluded, “The identification of noninvasive biomarkers to assess Alzheimer’s disease treatments is crucial to the continued advancement of clinical research and medical care for Alzheimer's disease. We are grateful to the NIA for their continued support in helping to advance our understanding – and the understanding of the entire healthcare community – of the potential that qEEG holds in the diagnosis of Alzheimer’s disease and the measurement of therapeutic impact.”
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a clinical stage biopharmaceutical company developing small-molecule therapeutics that address the toxic oligomeric proteins that cause synapse degeneration and trigger neurodegenerative conditions such as Alzheimer’s disease.
Cognition’s lead candidate, Elayta™, is a novel first-in-class, orally available small molecule that has shown the potential in initial clinical studies to normalize protein trafficking and lipid metabolism pathways that are disrupted in Alzheimer’s disease and to allow the protection and restoration of synapses. Elayta is currently being tested for the treatment of mild-to-moderate Alzheimer’s disease in three Phase 2 clinical studies: SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition); SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients); and SHINE (Synaptic Health and Improvement of Neurological Function with Elayta). These studies are supported by grants (award numbers RF1AG057780, RF1AG057553 and R01AG058660) from the National Institute on Aging of the NIH. Elayta has been granted Fast Track designation by the U.S. FDA.
Elayta and Cognition’s other pipeline candidates were identified using the company’s disease-relevant screening and novel chemistry platforms. Additional information about Cognition and its product candidates may be found online at http://www.cogrx.com.
This press release contains “forward-looking statements” concerning the development and commercialization of Cognition’s products, the potential benefits and attributes of such products, and Cognition’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Cognition undertakes no obligation to update any forward-looking statements for any reason.
Cognition Therapeutics, Inc.