Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416072
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-10
First Post:
2023-02-21
Brief Title:
Alzheimers Plasma Extension
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Alzheimers Plasma Extension
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
APEX
Brief Summary:
The APEX study is a multicenter observational study designed to capture longitudinal follow-up of plasma biomarkers and cognitive and functional assessments on individuals who screen failed in the AHEAD study over approximately 4 years
Approximately 1000 participants will be enrolled across three groups
Group A Approximately 500 participants who are discordant on screening plasma positive Positron Emission Tomography PET negative
Group B Approximately 250 participants who are concordant on screening plasma negative PET negative and
Group C Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimers disease AD clinical trials
Primary Objectives
Collect longitudinal cognitive and functional assessments and blood-based biomarker data
Evaluate characterize and compare the longitudinal cognitive and functional data between the three groups of participants
Compare longitudinal change across race and ethnicity sex and Apolipoprotein E ApoE status
Exploratory Objectives
Collect baseline amyloid PET on participants without prior amyloid PET data Group C
Approximately 1000 participants will be enrolled across three groups
Group A Approximately 500 participants who are discordant on screening plasma positive Positron Emission Tomography PET negative
Group B Approximately 250 participants who are concordant on screening plasma negative PET negative and
Group C Approximately 250 participants selected from the individuals who previously screen failed prior to PET for the AHEAD study with oversampling of racial and ethnic populations underrepresented in Alzheimers disease AD clinical trials
Primary Objectives
Collect longitudinal cognitive and functional assessments and blood-based biomarker data
Evaluate characterize and compare the longitudinal cognitive and functional data between the three groups of participants
Compare longitudinal change across race and ethnicity sex and Apolipoprotein E ApoE status
Exploratory Objectives
Collect baseline amyloid PET on participants without prior amyloid PET data Group C
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG054029 | NIH | None | httpsreporternihgovquickSearch5R01AG054029 |