Phase 2 SHIMMER Study Enrollment Complete for CT1812 in DLB; Results Due in 2024

Cognition Therapeutics, a biopharmaceutical firm listed on NASDAQ as CGTX, has successfully completed enrollment for its Phase 2 SHIMMER clinical trial (COG1201, NCT05225415). The study is focused on evaluating the efficacy and safety of CT1812 in adults diagnosed with mild to moderate dementia associated with Lewy bodies (DLB). The company anticipates releasing primary data in the latter half of 2024, post the conclusion of a six-month treatment period for the final participants.
DLB, a neurodegenerative condition affecting an estimated 1.4 million Americans, currently lacks any approved treatments that can alter the disease's course. The disease is characterized by the presence of both Aβ and α-synuclein pathologies, making it difficult to diagnose and treat. Cognition Therapeutics' CEO, Lisa Ricciardi, highlighted the potential of CT1812 due to its unique dual-target mechanism, which could mitigate disease progression.
The SHIMMER trial employs a double-blind, placebo-controlled design and has enrolled 120 adults with DLB. Participants are randomly assigned to receive either a placebo or one of two daily doses of CT1812 (100 mg or 300 mg) for six months. The study's outcomes will be measured using recognized cognitive and executive function scales such as the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR). Additionally, the study will analyze biomarker data to assess disease modification and the drug's interaction with its target.
CT1812 is an experimental oral medication designed to cross the blood-brain barrier and selectively bind to the sigma-2 (σ-2) receptor complex. This receptor complex plays a critical role in cellular processes like membrane trafficking and autophagy, which are disrupted in neurodegenerative diseases. The drug is also being investigated in other clinical trials for Alzheimer's disease and age-related macular degeneration.
Cognition Therapeutics is a clinical-stage company dedicated to developing therapeutics for age-related neurodegenerative and retinal disorders. The company's lead candidate, CT1812, and its pipeline of σ-2 receptor modulators are believed to have the potential to regulate pathways impaired in these diseases, offering a novel approach to treatment.