Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT04141150
Status:
UNKNOWN
Last Update Posted:
2023-06-15
First Post:
2019-10-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects
Sponsor:
APRINOIA Therapeutics, LLC
Organization:
Study Overview
Official Title:
A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
Detailed Description:
The overall objective of this study is to compare the overall pattern of \[18F\]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
The specific objectives are:
* To expand the safety and tolerability profile for the administration of \[18F\]APN-1607 and PET scanning.
* To assess regional patterns of \[18F\]APN-1607 uptake.
* To determine the Braak stage equivalent reflected by \[18F\]APN-1607 uptake patterns.
* To evaluate the relationship between regional measures of \[18F\]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).
The specific objectives are:
* To expand the safety and tolerability profile for the administration of \[18F\]APN-1607 and PET scanning.
* To assess regional patterns of \[18F\]APN-1607 uptake.
* To determine the Braak stage equivalent reflected by \[18F\]APN-1607 uptake patterns.
* To evaluate the relationship between regional measures of \[18F\]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).
Study Oversight
Has Oversight DMC:
True
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?: