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Cognition Therapeutics is Recruiting for Lewy Body Dementia Phase 2 SHIMMER Trial in Seventeen Research Sites Across the U.S.

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Cognition Therapeutics, Inc. (Nasdaq: CGTX) is recruiting participants for the SHIMMER Phase 2 clinical trial of CT1812, aimed at treating Lewy Body Dementia (LBD), with over 1.4 million Americans affected. This trial will include 120 adults aged 50 to 80 and analyze cognitive and physical changes over six months. Supported by $30M in NIH grants, the study is crucial given the lack of approved treatments for LBD. The company aims to raise awareness about this often-misdiagnosed condition during Lewy Body Dementia Awareness Month.

Positive
  • SHIMMER Phase 2 trial actively recruiting participants across 17 sites, increasing potential patient access.
  • Trial supported by $30M in grants from the National Institutes of Health, enhancing financial stability.
  • Focus on a significant unmet medical need with LBD, potentially positioning CT1812 as a market leader if successful.
Negative
  • No current approved treatments for LBD could indicate high risk and uncertainty surrounding trial outcomes.

Estimated Over 1.4 Million Americans Suffer from LBD – Often Misdiagnosed – No Approved Treatments

PURCHASE, N.Y., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Lewy Body Dementia (LBD) patients are actively being recruited by Cognition Therapeutics, Inc. (Nasdaq: CGTX) and its clinical partners for the SHIMMER Phase 2 trial of their CT1812 oral drug therapy at 17 study sites across the country with more expected to open.

“The Phase 2 SHIMMER study (NCT05225415) is actively recruiting participants for these sites across the United States, including those that are Lewy Body Dementia Association centers of excellence” added Anthony O. Caggiano, M.D., Ph.D., Cognition’s chief medical officer and head of R&D. “We look forward to working together with our partners to activate the remaining study sites across the country so that patients have local options.”

This month is Lewy Body Dementia Awareness month with approximately over 1.4 million people in the United States suffering from the neurodegenerative disease, making it the second most common form of dementia. Often misdiagnosed it also masks itself as Parkinson’s disease and is the largest dementia most have never heard of.

"Patients with LBD can present initially with different symptoms, making it challenging for general practitioners or even neurologists to recognize,” explained James E. Galvin, MD, MPH, the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and primary investigator for the SHIMMER study. “In addition, the stigma that exists around mental health can lead patients to under-report neuropsychiatric symptoms, such as hallucinations, which are common in early stages of LBD. This October, during Lewy Body Dementia Awareness Month, let’s recommit to educating ourselves about LBD.”

SHIMMER is supported by $30M in grants by the National Institutes of Health’s National Institute on Aging (NIA). The study is a double-blind Phase 2 clinical trial designed to enroll 120 adults between 50 and 80 years of age with a LBD diagnosis, who will be randomized to receive a placebo or one of two daily oral doses of CT1812 for six months. In addition to safety, this study will compare changes in cognitive performance, physical activity, and pharmacokinetic and pharmacodynamic biomarkers to baseline measurements. To learn more about the SHIMMER study and site locations please visit www.shimmerDLBstudy.com.

About Cognition Therapeutics, Inc.
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.

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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our cash and financial resources and our clinical development plans, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition, our ability to secure new (and retain existing) grant funding, our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto (including with respect to patient recruitment efforts); the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; issues related to supply chain and the labor force; and the risks and uncertainties described in the “Risk Factors” section of our filings made with the Securities Exchange Commission. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact Information: 
Cognition Therapeutics, Inc. 
info@cogrx.com

Monique Tapie (media) 
Shadwell Global Partners
mtapie@shadwellgp.com
   
Daniel Kontoh-Boateng/Rosalyn Christian (investors) 
Tiberend Strategic Advisors, Inc.
dboateng@tiberend.com
rchristian@tiberend.com

 


FAQ

What is the SHIMMER Phase 2 trial by Cognition Therapeutics for?

The SHIMMER trial aims to evaluate the efficacy of CT1812 in treating Lewy Body Dementia (LBD).

When did Cognition Therapeutics announce the SHIMMER Phase 2 trial?

The announcement was made on October 12, 2022.

What is the target enrollment for the SHIMMER Phase 2 trial?

The trial aims to enroll 120 adults aged 50 to 80 diagnosed with LBD.

How long will the SHIMMER trial last?

The trial will last for six months, where participants will receive either a placebo or CT1812.

What potential impact could the SHIMMER trial results have on Cognition Therapeutics?

Successful results may position CT1812 as a key treatment for LBD, significantly impacting revenue and market position.

Cognition Therapeutics, Inc.

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Biotechnology
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