Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT06961760
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2025-11-21
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program for CT1812 (Zervimesine)
Sponsor:
Cognition Therapeutics
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: