Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2025-12-16 @ 10:29 PM
Study NCT ID:
NCT04798989
Status:
None
Last Update Posted:
2024-10-30 00:00:00
First Post:
2021-03-11 00:00:00
Brief Title:
A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology
Sponsor:
Tisento Therapeutics
Organization:
Tisento Therapeutics
Study Overview
Official Title:
A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 When Administered to Participants With Alzheimer's Disease and Vascular Pathology
Status:
None
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to enrollment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CY6463 is an investigational drug being developed as a symptomatic and potentially disease-modifying therapy for Alzheimer's disease (AD) and other serious central nervous system disorders. As a soluble guanylate cyclase (sGC) stimulator, CY6463 can cross the blood-brain barrier and boosts the activity of the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate (NO-sGC-cGMP) pathway. This signaling pathway is important in many aspects of brain health, including in the control of blood flow in the brain, how brain cells use energy, and how those cells communicate with one another. Impairment of this pathway is a critical part of the origin of many neurodegenerative diseases that can cause a loss of brain function including memory and decision-making abilities. There are clear links between disrupted NO signaling and impaired brain function in patients with AD and vascular pathology (ADv). ("Vascular pathology" refers to abnormalities of the blood vessels that are more likely to occur when a person has cardiovascular risk factors like high blood pressure, diabetes, and/or obesity.) It is hypothesized that CY6463 may help patients with ADv maintain or recover some of their original cognitive function.
In this study, participants will be randomized to receive approximately 87 sequential days (\~3 months) of study drug (CY6463 or placebo) once daily (QD) and will complete 7 scheduled site visits over the course of the study, from Screening through Follow up.
In this study, participants will be randomized to receive approximately 87 sequential days (\~3 months) of study drug (CY6463 or placebo) once daily (QD) and will complete 7 scheduled site visits over the course of the study, from Screening through Follow up.
Detailed Description:
CY6463 is an investigational drug being developed as a symptomatic and potentially disease-modifying therapy for Alzheimers disease AD and other serious central nervous system disorders As a soluble guanylate cyclase sGC stimulator CY6463 can cross the blood-brain barrier and boosts the activity of the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate NO-sGC-cGMP pathway This signaling pathway is important in many aspects of brain health including in the control of blood flow in the brain how brain cells use energy and how those cells communicate with one another Impairment of this pathway is a critical part of the origin of many neurodegenerative diseases that can cause a loss of brain function including memory and decision-making abilities There are clear links between disrupted NO signaling and impaired brain function in patients with AD and vascular pathology ADv Vascular pathology refers to abnormalities of the blood vessels that are more likely to occur when a person has cardiovascular risk factors like high blood pressure diabetes andor obesity It is hypothesized that CY6463 may help patients with ADv maintain or recover some of their original cognitive function
In this study participants will be randomized to receive approximately 87 sequential days 3 months of study drug CY6463 or placebo once daily QD and will complete 7 scheduled site visits over the course of the study from Screening through Follow up
In this study participants will be randomized to receive approximately 87 sequential days 3 months of study drug CY6463 or placebo once daily QD and will complete 7 scheduled site visits over the course of the study from Screening through Follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None