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NCT06416072 · ClinicalTrials.gov registry record
Alzheimer's Plasma Extension
A clinical trial of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, sponsored by University of Southern California.
- Active
- Registry status
- 1,000
- Enrollment target
- 20
- Study locations
NCT06416072 is a study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 1,000 participants, above the 646-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT06416072, a study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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 Alzheimer's 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)
Conditions Studied
Interventions
- RADIATION NAV4694
Study Locations (20)
Florida
- Brain Matters Research - Delray Beach
- Mayo Clinic, Jacksonville - Jacksonville
- K2 Medical Research - The Villages - Lady Lake
- K2 Medical Research, LLC - Maitland
- Gonzalez MD & Aswad MD Health Services - Miami
- Wien Center for Clinical Research - Miami Beach
- Charter Research - Orlando
- University of South Florida - Health Byrd Alzheimer Institute - Tampa
California
- University of California, Irvine - Irvine
- University of Southern California - Los Angeles
- Stanford University - Palo Alto
- Sharp Neurocognitive Research Center - San Diego
- University of California, San Francisco - San Francisco
- University of California, Davis - Walnut Creek
Arizona
- Banner Alzheimer's Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
District of Columbia
- Georgetown University - Washington D.C.
- Howard University - Washington D.C.
Alabama
- University of Alabama, Birmingham - Birmingham
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2028-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06416072
The ClinicalTrials.gov registry entry for NCT06416072 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 646-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (55% higher). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Preclinical Alzheimer's Disease appearing as the primary indexed condition, and to 1 intervention - of which NAV4694 is the first listed.
NCT06416072 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06416072 about?
NCT06416072 is a clinical study titled "Alzheimer's Plasma Extension". 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...
What is the current status of trial NCT06416072?
This trial is currently active not recruiting. The enrollment target is 1,000 participants. The study started on 2023-09-21. Estimated completion is 2028-06.
What conditions does trial NCT06416072 study?
This clinical trial studies the following conditions: Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease.
What interventions are being tested in trial NCT06416072?
The interventions under investigation include: NAV4694 (RADIATION).
Who is sponsoring clinical trial NCT06416072?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06416072 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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