NCT06961760

Expanded Access Program for CT1812 (Zervimesine)

A Single-arm, Open-label, Expanded Access Program to Provide 100 mg CT1812 (Zervimesine) and to Collect Long-term Safety and Efficacy Data in Participants With Mild-to-moderate Dementia With Lewy Bodies (DLB).

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 86 Years
• Healthy volunteers: —

Summary

This is a multi-center, open label, expanded access program (EAP) that will provide 100 mg CT1812 for up to one year to participants with mild-to-moderate DLB.

Detailed description

Participants will be screened for eligibility by physical, laboratory, psychometric and neurologic examinations. After having met all inclusion criteria, and none of the exclusion criteria, participants will be enrolled. The first dose will be taken in the clinic. Participants and their caregivers/study partner will have a study visit clinic for repeat psychometric/neurologic testing, safety procedures and lab sample collection. Each participant and caregiver/study partner will participate in a screening period of up to 7 days, followed by an open label treatment period of 360 (± 4 days) days and a follow up visit at day 390 (± 2 days) for a maximum of 397 days of study participation including screening.

Conditions

• Dementia With Lewy Bodies

Interventions

Type	Name	Description
DRUG	zervimesine	Zervimesine (CT1812) was shown to be safe and well tolerated in a study of healthy volunteers and in Phases 1 and 2 studies of participants with mild to moderate AD and DLB. This is an open label expanded access program designed to provide access to CT1812 and to evaluate the long-term safety of CT1812 administered once daily for 12 months in adults aged 50 to 86 who have been diagnosed with mild to moderate DLB (the targeted clinical indication for CT1812). Participants will receive 100 mg of CT1812 once daily for 360 days.

Timeline

• First posted: 2025-05-08
• Last updated: 2025-11-21

Locations

8 sites across 1 country: United States