Cognition Therapeutics Publishes EEG Findings from Phase 2 SEQUEL Study of CT1812 in Mild-to-Moderate Alzheimer's Disease

PURCHASE, N.Y., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, today announced that results from the SEQUEL study of CT1812, the Company's lead candidate for the treatment of Alzheimer's disease, were published in The Journal of Prevention of Alzheimer's Disease. SEQUEL was a single-site study that measured brain wave patterns in 16 adults with mild-to-moderate Alzheimer's disease following 29-days of treatment with CT1812 or placebo. In this study, CT1812-treated participants exhibited consistent trends of improvement across all prespecified electroencephalography (EEG) parameters with several reaching significance, including the change in relative theta power in the central region (p=0.006) of the brain and AEC-c* (p=0.034), which assesses the connectivity between brain regions.

"The gradual slowing of brain wave patterns and impaired connectivity that is a hallmark of Alzheimer's disease is due to the loss of synapses, which are the connection points between neurons," stated Anthony O. Caggiano, MD, PhD, chief medical officer and head of R&D at Cognition Therapeutics. "Quantitative qEEG is a sensitive method of measuring the electrical activity of neurons in the brain. The changes we observed across EEG parameters in SEQUEL may indicate that CT1812 is normalizing brain wave patterns and facilitating communication between different brain regions. We believe that CT1812 was able to rescue these early deficits by protecting synapses through its unique mechanism as an Aβ oligomer antagonist."

In the SEQUEL study, treatment with once-daily oral CT1812 produced a consistent reduction in global relative theta power and in relative theta power in frontal, temporal, parietal, occipital and central brain regions. Increasing prominence of slower EEG frequencies (4-8 Hz) termed "theta" and a declining prominence of "alpha" frequencies (8-12 Hz) are associated with cognitive decline in people with Alzheimer's disease. This improvement in global and relative theta power was coupled with an observed improvement in global alpha AEC-c, a measure of connectivity between brain regions, which has been found to be highly predictive of changes in cognitive function in Alzheimer's disease. Together, the improvement in AEC-c and the shift in brain wave from theta towards faster alpha frequencies we believe supports our thesis that CT1812 has a unique neuroprotective mechanism that may normalize synaptic function.

CT1812 was observed to be well tolerated with mild or moderate treatment emergent adverse events (TEAEs) occurring in 11 patients in the CT1812-treated arm and 6 on placebo. The six treatment-related AEs were diarrhea, nausea, and vomiting with placebo; diarrhea, nausea, and hepatic enzyme elevation with CT1812. No AEs lead to discontinuation and no severe or serious AEs or deaths were reported among CT1812-treated participants.

These results and other details of the study may be found in the open-access article in The Journal of Prevention of Alzheimer's Disease, titled "A Pilot Electroencephalography Study of the Effect of CT1812 Treatment on Synaptic Activity in Patients with Mild to Moderate Alzheimer's Disease." This and Cognition's other published articles may be found on the Company's Publication webpage.

* Note: AEC-c = corrected amplitude envelope correlation

About the SEQUEL Study

The SEQUEL study enrolled 16 adults (15 of whom completed the study) with mild-to-moderate Alzheimer's disease (MMSE 18-26), each of whom were randomized to receive either 300mg CT1812 or placebo once daily for 29 days. After a 14-day wash-out period, participants cross over into the other treatment arm for an additional 29 days. Quantitative EEG evaluations were taken periodically throughout the duration of the trial. SEQUEL was designed to assess the safety and efficacy of CT1812 and to measure the impact of CT1812 on the electrical activity in the brain, specifically those electrical impulses in the theta band.

SEQUEL was supported by $5.3 million in grant awards (R01AG058710) by the National Institute of Aging (NIA) of the National Institutes of Health (NIH).

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. Preclinical and clinical data demonstrate that this binding results in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer's 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) of CT1812 in adults with dementia with Lewy bodies and the aforementioned SHINE Study.

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

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