Cognition Therapeutics Announces all Participants have Completed their Final Visits in the Phase 2 SHIMMER Study of CT1812 in Dementia with Lewy Bodies

– Topline results in second dementia indication expected to be reported in December 2024 –

PURCHASE, N.Y., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB). The Company anticipates that topline results will be available in December 2024.

"We would like to extend our appreciation to the patients and caregivers who participated in our study, without whom we would not have been able to accomplish this goal. In addition, we would like to thank our investigators, our partners at the National Institute of Aging and the Lewy Body Dementia Association (LBDA) and the greater DLB awareness community for their tireless commitment," stated Anthony Caggiano, M.D., Ph.D., Cognition's chief medical officer and head of R&D.

Lisa Ricciardi, Cognition's president and CEO, concluded, "We look forward to reviewing the results of this study to enhance our understanding of CT1812's tolerability profile and identify signals of efficacy across measures of cognition and function."

About Dementia with Lewy Bodies (DLB)

Dementia with Lewy bodies is the second most common cause of dementia, affecting an estimated 1.4 million Americans. The disease is believed to be caused by a buildup of the protein α-synuclein, which aggregates in Lewy bodies, which are found within brain neurons. DLB is referred to as a "whole-body" disease, as it disrupts biological processes affecting autonomic, digestive, cognitive, and motor systems. Varied initial symptoms may include day-to-day fluctuations in alertness level, hallucinations, delusions, movement disorders and REM sleep disorder (acting out dreams while sleeping). Only a few symptomatic treatments for DLB are approved and currently there are no disease-modifying therapeutics.

About the SHIMMER Study

The SHIMMER study is a double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants were evenly randomized to receive either placebo or one of two oral once-daily doses of CT1812 (100 mg or 300 mg) for six months. Participants are assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.

The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million and is being conducted 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). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence.

About CT1812 

CT1812 is an experimental orally delivered small molecule oligomer antagonist that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex, which is involved in the regulation of key cellular processes. These processes are disrupted by toxic interaction with Aβ or α-synuclein oligomers, oxidative stress and other disease drivers. The ensuing damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and disease progression.  

Participants are currently being recruited in the START study (NCT05531656) of CT1812 in adults with early Alzheimer's disease; and the MAGNIFY study (NCT05893537) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration. Enrollment has completed in the SHIMMER study (NCT05225415) in adults with dementia with Lewy bodies and the SHINE study (NCT03507790) in mild-to-moderate Alzheimer's disease.   

About Cognition Therapeutics, Inc. 

Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are 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 that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.

Forward-Looking Statements

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