Cognition Therapeutics, Inc. has announced positive results from a Phase 2 trial of CT1812 (zervimesine)in patients with mild to moderate dementia with Lewy bodies (DLB). CT1812 is an orally delivered small molecule that selectively binds to the sigma-2 receptor complex. CT1812 binding to this complex helps to break down oligomers associated with neurodegenerative diseases like DLB by reducing their ability to form plaques and disrupt neuronal function.
The Phase 2, exploratory, double-blind SHIMMER study randomized 130 patients 1:1:1 with mild to moderate DLB to daily treatment with CT1812 100 mg, CT1812 300 mg, or placebo for 24 weeks. The study met its primary endpoint of safety and tolerability.
The study also demonstrated positive results across several key efficacy secondary endpoints. Notably, 82% of patients in the CT1812 treatment arms showed a slowing of the total neuropsychiatric inventory (NPI), a composite measure to track neurological condition progression. Particularly strong improvements were shown on NPI subscales of anxiety, hallucinations, and delusions in CT1812 treatment arms. Also, patients treated with CT1812 experienced a slower decline in cognitive measures compared to placebo. Caregivers of those treated with CT1812 reported less distress, suggesting the treatment tangibly improved patients’ experience of daily living, highlighting the promise of CT1812 for people living with DLB.
Other secondary measures related to progressive movement disorders, including the Montreal Cognitive Assessment Scale and the Movement Disorder Society – United Parkinson’s Disease Rating Scale Part III, presented at the International Lewy Body Dementia Conference January 29-31, 2025, in Amsterdam. These results are likely to support future exploration of the clinical application of CT1812 for neurodegenerative motor symptoms and movement disorders.
“These topline results exceeded our expectations and support the broad potential of CT1812 across neurodegenerative disorders,” said Anthony Caggiano, MD, PhD, Cognition’s CMO and head of R&D. CT1812 is being explored for other clinical applications, including a Phase 2 study in patients with mild to moderate Alzheimer’s disease. Clinical studies for neurodegenerative diseases like DLB hinge on patient identification and recruitment, which can be aided by efficient laboratory tests.
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