Extension of Expanded Access Program for Zervimesine to Treat Dementia With Lewy Bodies

An extension has been announced for the expanded access program of zervimesine to treat dementia with Lewy bodies.¹ The original expanded access program was planned for 12 months, and the extension will now add several more months of treatment for patients.

“The EAP has been running since June 2025 and is expected to provide us with additional long-term safety data,” explained Anthony Caggiano, MD, PhD, Cognition's chief medical officer, in a press release.¹ “We’ve received favorable feedback during the program from participants and their care partners about their experience in this program. We implemented a strategy that reduces the amount of travel for patients to clinical sites by empowering their local physicians to conduct routine health monitoring and allowing local laboratory testing. Doctors and patients appreciate these operational aspects of the program,” he emphasized.

In the open label expanded access program, 32 participants were enrolled at 8 sites. Patients were treated with 100 mg of zervimesine daily. Continued access through the program is open to eligible SHIMMER study participants who completed the phase 2 trial and other patients diagnosed with mild to moderate dementia with Lewy bodies meeting enrollment criteria. The SHIMMER study initially found safety and tolerability endpoints met, with participants showing improved symptoms as measured by the neuropsychiatric inventory.²

David Shprecher, DO, MSci, led the first site which enrolled participants, and stated that “the Cognition team sought input from myself and other investigators in the design of this EAP to maximize the number of participants who could enroll with the limited resources available,” explained Shprecher.¹ “With only 8 clinical sites around the country able to participate, patients would need to travel long distances for clinic visits. Working together, we devised a system that would enable patients to see their local doctors for routine visits while traveling to clinic sites for more rigorous monitoring.”

Zervimesine (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.³ In previous preclinical studies, zervimesine was shown to antagonize binding of A-beta oligomers to neuronal synapses, protect neuronal synapses, and restore membrane trafficking deficits cause by A-beta oligomers.⁴

The expanded access program is included in the larger clinical development of zervimesine for dementia with Lewy bodies. Current development includes the phase 2 SHIMMER study and other clinical programs. Recently, Cognition Therapeutics, the company developing the drug, held a type C meeting with the US Food and Drug Administration to review findings of the SHIMMER study.⁵ The type C meeting elaborated on clinically meaningful endpoints for future studies of dementia with Lewy bodies, the company noted. Minutes from this meeting are expected in February.

References

1. Cognition Therapeutics extends expanded access program for zervimesine (CT1812) in dementia with Lewy bodies. Press release. February 5, 2026. Accessed February 5, 2026. https://www.globenewswire.com/news-release/2026/02/05/3232883/0/en/Cognition-Therapeutics-Extends-Expanded-Access-Program-for-Zervimesine-CT1812-in-Dementia-with-Lewy-Bodies.html

2. 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

3. 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.

4. Limegrover CS, LeVine H 3rd, Izzo NJ, et al. Alzheimer's protection effect of A673T mutation may be driven by lower Aβ oligomer binding affinity. J Neurochem. 2021;157(4):1316-1330.

5. Walters J. Type C meeting with FDA completed for zervimesine in dementia with Lewy bodies. Psychiatric Times. January 27, 2026. https://www.psychiatrictimes.com/view/type-c-meeting-with-fda-completed-for-zervimesine-in-dementia-with-lewy-bodies