Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Alzheimer's Plasma Extension
NCT06416072 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06416072 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06416072?
The interventions under investigation include: NAV4694 (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06416072?
This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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