Type C Meeting With FDA Completed for Zervimesine in Dementia With Lewy Bodies

Cognition Therapeutics announced completion of a type C meeting with the US Food and Drug Administration (FDA) this week. The meeting covered proposed plans for the phase 2b study of zervimesine to treat dementia with Lewy bodies, which currently has no FDA approved treatments.

“We had a productive meeting with the FDA, during which we discussed clinically meaningful endpoints for the next phase 2b study of mild-to-moderate [dementia with Lewy bodies],” stated Anthony O. Caggiano, MD, PhD, Cognition’s chief medical officer, in a press release. “We look forward to receiving meeting minutes later this quarter and continuing our dialogue with the FDA to advance clinical development in [dementia with Lewy bodies],” he added.

Zervimesine is currently being investigated as a once-daily oral pill treatment for central nervous system diseases like Alzheimer disease and dementia with Lewy bodies. Zervimesine (also known as CT1812) is a sigma-2 receptor modulator that blocks binding and displaces a-beta and alpha-synuclein oligomers from receptor sites to preserve neuronal synapses and normalize neural functioning.² Dementias like these are associated with a-beta and alpha-synuclein protein buildup in the brain. As protein buildup continues, progressive loss of abilities like learning, memory recall, and communication can occur. By preventing oligomer binding at synapses, zervimesine is intended to preserve synaptic integrity and normalize downstream neuronal signaling. Preclinical and clinical data suggest that oligomer displacement may reduce synaptic toxicity, which is believed to be a key driver of cognitive and functional impairment in neurodegenerative dementias.

Zervimesine has so far been shown to reduce effects of these harmful proteins associated with dementias, potentially slowing disease progression and improving symptoms. The drug also has been well-tolerated, as seen in clinical studies thus far. The most recent phase 2 SHIMMER study met primary endpoints for safety and tolerability and showed improvement in activities of daily living.³

The type C meeting is a non-milestone meeting between a drug sponsor and the FDA to discuss development of a product. Meeting information may include protocols, study design, and regulatory strategy.^4,5 Minutes from this meeting are expected to be released later this quarter, and the company plans to further evaluate and advance the phase 2b development of zervimesine in dementia with Lewy bodies. Continued clinical progress may represent an important step toward addressing a substantial unmet need in this challenging neurodegenerative disease.

References

1. Cognition Therapeutics completes type C meeting with FDA for zervimesine (CT1812) in dementia with Lewy bodies. Press release. January 27, 2026. Accessed January 27, 2026. https://finance.yahoo.com/news/cognition-therapeutics-completes-type-c-123000398.html

2. Galvin JE, Tolea MI, Scharre DW, et al. Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB). Alzheimer's Dement. 2025;21:e71004.

3. Walters J. Zervimesine may slow progression of dementia with Lewy bodies, phase 2 results show. Psychiatric Times. January 6, 2026. https://www.psychiatrictimes.com/view/zervimesine-may-slow-progression-of-dementia-with-lewy-bodies-phase-2-results-show

4. Guidance for industry: formal meetings between the FDA and sponsors or applicants. US Food and Drug Administration. 2009. Accessed January 27, 2026. https://www.fda.gov/media/72253/download
5. Understanding type C FDA meetings: a flexible forum for regulatory guidance. Facet Life Sciences. March 9, 2025. Accessed January 27, 2026. https://facetlifesciences.com/2025/03/09/type-c-fda-meetings/