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Cognition Therapeutics Initiates NIA-Funded SPARC Study of Elayta™ to Assess Changes in Synaptic Density and Cognitive Performance in Alzheimer's Disease
First Longitudinal Study of Novel Synaptic Imaging Agent at Yale Alzheimer's Disease Research Unit and Yale PET Center
Pittsburgh, June 18, 2018 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on synaptic health and restoration in neurocognitive disorders, today announced that patient dosing has begun in the SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition) study of Elayta™ (CT1812), Cognition’s lead candidate for the treatment of mild-to-moderate Alzheimer’s disease.
SPARC (COG0105) is a randomized, double-blind, placebo-controlled study designed to compare changes in synaptic density in 21 Alzheimer’s disease patients who will receive treatment with Elayta or placebo once daily for 24 weeks. Synaptic density will be determined at baseline and after 12 and 24 weeks of dosing using positron emission tomography (PET) imaging with a carbon-11-labeled radioligand tracer, UCB-J, that is selective for synaptic vesicle glycoprotein 2A (SV2A), a membrane protein expressed in the majority of synapses. Patients will be enrolled at the Yale Alzheimer's Disease Research Unit under the direction of co-investigators Christopher van Dyck, M.D. and Richard E. Carson, Ph.D. The SPARC study is funded by a $4.1 million grant from the National Institute on Aging of the NIH under award number RF1AG057553.
“The link between synaptic density and cognitive function has been well characterized and is highly correlated with cognitive decline in Alzheimer’s disease. If synapse numbers stabilize or increase in these Alzheimer’s disease patients after Elayta treatment compared to placebo, the SPARC study could yield very important insights for the Alzheimer’s disease community,” said Dr. van Dyck, director of the Yale Alzheimer's Disease Research Unit, and a professor of psychiatry, neurology and neuroscience.
“This is the first longitudinal study of the [11C]UCB-J imaging agent in patients with Alzheimer’s disease,” stated Dr. Carson, the director of the Yale PET Center and director of Yale graduate studies in biomedical engineering, and professor of radiology, biomedical imaging and biomedical engineering. He added, “Alzheimer’s disease patients experience a degeneration of synapses, caused in part by the binding of toxic Aβ oligomers (AβOs) to neuronal receptors. This methodology has the potential to quantify synaptic density in the brain and, as a result, to become an important tool in the development of new therapies for Alzheimer’s disease and other neurocognitive disorders.”
“PET imaging of SV2A in SPARC has the potential to demonstrate Elayta’s synaptorestorative effect in patients with Alzheimer’s disease. Further, we expect that the increase in synaptic density will correlate with improved cognition and function among trial participants,” stated Cognition co-founder and Chief Science Officer Susan Catalano, Ph.D. “Elayta’s unique synaptorestorative mechanism of action indirectly destabilizes the AβO binding site, thereby displacing AβOs from synapses and clearing them out of the brain into the cerebrospinal fluid. We have shown in vitro that synaptic density returns to normal levels following treatment with Elayta and look forward with great anticipation to the results of the SPARC trial.”
More information about SPARC is available at www.ClinicalTrials.gov.
About Elayta (CT1812)
Cognition’s lead product candidate, Elayta (CT1812), a highly brain penetrant small molecule with a unique disease-modifying synaptorestorative mechanism of action, is currently in Phase 2 clinical testing for mild-to-moderate Alzheimer’s disease. This orally dosed drug candidate facilitates the restoration and protection of synaptic function by selectively displacing toxic beta amyloid oligomers (AβOs) from their synaptic receptors, thus stopping downstream damage and improving memory function. Consistent with these findings, Cognition’s Phase 1b/2 clinical trial (COG0102) demonstrated that Elayta significantly reduces concentrations of synapse damage proteins in the cerebrospinal fluid of Alzheimer’s patients. In addition to SPARC, patient dosing was recently initiated in the SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients) Study, in which the concentration of AβOs in the CSF after a single dose of either Elayta or placebo is being measured for 24 hours using novel highly sensitive methods of AβO measurement. Elayta has been granted Fast Track designation by the U.S. FDA.
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company focused on synaptic health and restoration in neurocognitive disorders through a pipeline of disease modifying small molecule drug candidates. Cognition’s lead candidate, Elayta, is a proprietary first-in-class, orally available small molecule that has shown synaptorestorative potential and is in development for the treatment of mild-to-moderate Alzheimer’s disease. 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.
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