Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514001
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Study of AMDX-2011P in Participants With Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess safety tolerability plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimers Disease AD
Detailed Description:
This open-label masked endpoint assessment study will evaluate the safety tolerability plasma pharmacokinetics PK and biological activity of an intravenous IV dose of AMDX-2011P in participants with AD Assessments of retinal images will be conducted by central masked assessors
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments retinal imaging and PK blood collection
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments retinal imaging and PK blood collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None