Cognition Therapeutics, Inc. secured a $75.8 million, five-year grant from the National Institute on Aging (NIA) of the National Institutes of Health (NIH) to support a 540-patient Phase II clinical trial of CT1812 in individuals with early Alzheimer’s disease. The study will be conducted in conjunction with the Alzheimer’s Clinical Trials Consortium (ACTC), an elite NIH-funded clinical trial network of 35 leading academic sites with expertise in Alzheimer’s disease.
A Competitive Process
It isn’t easy to secure such a large grant. Proposals to NIA for ACTC projects are highly competitive due in part to the ACTC’s limit of five-to-seven trials during any five-year award period as well as the NIA’s funding obligation outside of ACTC projects. Cognition has spent a year going through a rigorous application and review process for this study.
Ramping up with a Alzheimer’s Site & Trial Network
Now that Cognition has been selected the biotech is now working with collaborators at ACTC to educate member sites in preparation for commencing patient recruitment. Paul Aisen, MD, director of the Alzheimer’s Therapeutic Research Institute (ATRI) of the Keck School of Medicine at USC and a founding leader of the ACTC, will serve as project coordinator. Susan Catalano, PHD, co-founder and chief science officer of Cognition Therapeutics and Christopher van Dyck, MD director of the Yale Alzheimer’s Disease Research Center, will serve as co-primary investigators.
What is CT1812?
CT1812 is a brain-penetrant small-molecule drug that has been shown to target the signma-2 receptor, a key regulatory of the cellular damage response. By doing so, CT1812 displaces toxic Aβ oligomers from synapses and protects against further oligomer binding, potentially stopping the synapse damage and destruction that is characteristic of neurodegenerative diseases such as Alzheimer’s disease.
Highlighting the potential with this asset, Dr. Catalano emphasized that “Evidence suggests that Aβ oligomers exert their toxic effects on synapses long before symptoms of Alzheimer’s become apparent. She continued, “Because CT1812 is designed to prevent Aβ oligomers from binding to synapses, it may have the utility in a broad range of Alzheimer’s patients including those who are early in their disease progression. We look forward to exploring this potential with our esteemed colleagues at the ACTC.”
Work at Yale
Dr van Dyck commented on some of their observations at Yale concerning CT1812. Based on the progress at Yale “measuring synapses in vivo using PET imaging, we have been focused on the potential of CT1812 to preserve or even restore synapses.” He continued, “I’m looking forward to continuing our work together on this Phase II study to help determine the full potential of CT1812.”
The study is expected to enroll approximately 540 individuals with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease (MMSE 20-30) who have elevated Aβ (as measured by PET or CSF). Participants will be randomized to receive CT1812 or placebo for 18 months. In addition to a battery of cognitive measures, the study will use a variety of biomarkers to measure target engagement and assess changes in neurodegeneration and disease progression.
“This study presented an excellent opportunity for the ACTC to leverage our sizable and experienced community of Alzheimer’s trial sites to investigate the potential that CT1812 may have to preserve cognitive function for individuals at early stages of Alzheimer’s disease,” added Dr. Aisen. “We are grateful to NIA for their continued support of the ACTC and for their significant support of this study in particular.”
The Alzheimer’s Clinical Trials Consortium (ACTC)
The ACTC, funded by the National Institute on Aging at the National Institutes of Health (grant number U24AG057437), provides the infrastructure for academic clinical trials in Alzheimer’s disease and related dementias. The consortium, jointly based at the University of Southern California, Harvard University and the Mayo Clinic, includes expert units to support clinical trial design, biostatistics, informatics, medical safety, regulatory oversight, recruitment, clinical operations, data management, site monitoring, a biomarker laboratory and repository and neuroimaging. The ACTC includes 35 primary clinical sites across the United States.
Cognition Therapeutics, Inc. has discovered and is developing a pipeline of novel, disease modifying, oral drug candidates to treat a broad array of neurodegenerative disorders. Our molecules uniquely block the toxic action of protein oligomers in the CNS. Our lead asset, CT1812, targets the sigma-2 receptor and is in multiple Phase 2 trials for Alzheimer’s disease. Their Phase 2 study in collaboration with ACTC is supported by an $80 million competitive grant from the National Institute on Aging. The company, founded in 2007, has raised a total of about $81 million in venture capital as well.
Paul Aisen, MD, director of the Alzheimer’s Therapeutic Research Institute (ATRI) of the Keck School of Medicine at USC and a founding leader of the ACTC will serve as project coordinator
Susan Catalano, PHD, co-founder and chief science officer of Cognition Therapeutics
Christopher van Dyck, MD, director of the Yale Alzheimer’s Disease Research Center will serve as co-primary investigators.
Call to Action: Cognition Therapeutics secured a sizeable grant and now benefits from one of the most prominent network of Alzheimer’s investigators in the world. TrialSite News will monitor the drug and the company. Sign up for updates from the daily newsletter.