Cognition Therapeutics Highlights Phase 2 SHIMMER Study of CT1812 in Dementia with Lewy Bodies in Presentation at CTAD

Rhea-AI Summary

Cognition Therapeutics has announced the activation of up to 30 sites across the USA for its ongoing SHIMMER clinical trial evaluating CT1812, a novel treatment for dementia with Lewy bodies (DLB). This Phase 2 study aims to assess the safety and efficacy of CT1812, enrolling around 120 adults over six months. DLB currently lacks approved treatments, affecting approximately 1.4 million people in the U.S. The trial is supported by a $30 million grant from the National Institute on Aging and aims to provide crucial insights into cognitive and physical activity changes in DLB patients.

Positive

• The SHIMMER trial is enrolling patients at up to 30 activated sites, increasing research capabilities.
• CT1812 targets dementia with Lewy bodies, a condition with significant unmet medical needs.
• Study funded by a $30 million non-dilutive grant from the National Institute on Aging.
• Initial research shows CT1812's potential to reverse trafficking deficits caused by α-synuclein.

Negative

• None.

Innovative trial addresses second most common dementia after Alzheimer’s disease, now enrolling patients at up to 30 activated sites across the USA

PURCHASE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the rationale and design of the Company’s ongoing SHIMMER clinical trial of CT1812 will be presented at the 2022 Clinical Trials in Alzheimer’s Disease (CTAD) conference. The Phase 2 SHIMMER (COG1201) study is intended to assess the safety, tolerability, and efficacy of CT1812 in individuals with dementia with Lewy bodies (DLB). CT1812 is a novel oral, once-daily small-molecule therapeutic designed to protect neurons from pathogenic forms of proteins such as α-synuclein and beta amyloid (Aβ) by preventing oligomers from binding to synapses.

There are currently no approved treatments for DLB, which impacts an estimated 1.4 million people in the United States, making it the second most common form of dementia. Patients may present with symptoms including cognitive or motor deficits, or changes in behavior (sleep disorders, hallucinations, anxiety), which can masquerade as other conditions, making it challenging to correctly diagnose DLB. It is believed that aggregated forms of α-synuclein and Aβ bind to neurons, triggering failures in protein trafficking and other key cellular functions. Such a catastrophic failure in cellular function eventually leads to the loss of neurons, driving disease pathology and giving rise to the constellation of symptoms associated with DLB.

“We have published research¹ demonstrating that σ-2 receptor modulators such as CT1812 can be effective in reversing the trafficking deficits caused by α-synuclein oligomers in in vitro models,” stated Anthony Caggiano, M.D., Ph.D., chief medical officer and head of R&D at Cognition. “This proof-of-principle data, combined with the encouraging safety signals in our Alzheimer's disease program, gave us the confidence to move forward into our Phase 2 SHIMMER trial of CT1812 in DLB.”

The Company is conducting the study in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA) with non-dilutive grant funding of approximately $30 million from the National Institute on Aging (NIA). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence.

The Phase 2 SHIMMER trial will enroll approximately 120 adults with mild-to-moderate DLB, who will be randomized to receive placebo or once-daily oral doses of CT1812 for six months. In addition to safety, this study will compare changes in cognitive performance and physical activity using an innovative Clinical Global Impression of Change tool that has been modified to provide DLB-specific prompts on cognition, motor, behavioral, sleep and autonomic features. More details on the study and its inclusion and exclusion criteria may be found on www.clinicatrials.gov.

Poster details

Date/Time:	4:00pm PT on November 29th through 6:00pm PT on November 30th
Title:	A Phase 2 Study of the Sigma-2 Ligand CT1812 in Participants with Dementia with Lewy Bodies (P027)
Authors:	James Galvin, Magdalena Tolea, Michael Grundman, Mary Hamby, Anthony Caggiano

About Dementia with Lewy Bodies
An estimated 1.4 million Americans are living with DLB, a progressive disease that accounts for approximately 5-10% of all dementia cases. DLB has overlapping pathology and symptomology of Parkinson’s and Alzheimer’s diseases, making it challenging to diagnose. DLB is caused by a build-up of a protein, α-synuclein, which forms deposits, called Lewy bodies, in the brain. Oligomers of α-synuclein are highly toxic and bind to neurons where they impair critical cellular processes, causing synaptic dysfunction and loss. Patients with DLB often experience cognitive, physical, sleep and behavioral symptoms, including hallucinations, delusions and mood changes. There are currently no disease-modifying treatments approved for DLB patients.

About Cognition Therapeutics
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com/ 

¹ Limegrover CS et al. Sigma‐2 receptor antagonists rescue neuronal dysfunction induced by Parkinson’s patient brain‐derived α‐synuclein. J Neurosci Res. 2021; 00: 1– 16.

Forward-Looking Statements
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Contact Information:
Cognition Therapeutics, Inc.  
info@cogrx.com

Aline Sherwood (media)  
Scienta Communications  
asherwood@scientapr.com

Daniel Kontoh-Boateng / Rosalyn Christian (investors)  
Tiberend Strategic Advisors, Inc.  
dboateng@tiberend.com / rchristian@tiberend.com  

FAQ

What is the purpose of the SHIMMER clinical trial by Cognition Therapeutics?

The SHIMMER trial aims to evaluate the safety, tolerability, and efficacy of CT1812 in patients with dementia with Lewy bodies.

How many patients are being enrolled in the SHIMMER trial?

The SHIMMER trial will enroll approximately 120 adults with mild-to-moderate dementia with Lewy bodies.

What is the significance of CT1812 in treating dementia with Lewy bodies?

CT1812 is a novel therapeutic that aims to protect neurons from harmful proteins associated with dementia with Lewy bodies.

When will the results of the SHIMMER trial be available?

The SHIMMER trial is set to last six months, and results will be available following its completion.

What funding supports the SHIMMER trial?

The SHIMMER trial is supported by approximately $30 million in non-dilutive grant funding from the National Institute on Aging.