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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: Active study of Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, sponsored by University of Southern California.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Preclinical Alzheimer's Disease Early Preclinical Alzheimer's Disease

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

FieldValue
Enrollment Target 1,000 participants
Start Date 2023-09-21
Est. Completion 2028-06
University of Southern California

617 total trials

What the registry record for NCT06416072 still lists

NCT06416072 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 646-participant average among 3 other Preclinical Alzheimer's Disease trials with a reported enrollment target (55% higher).

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 names 20 study sites across 6 states, led by 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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Related registry views

Source: ClinicalTrials.gov NCT06416072, the US trial registry maintained by the National Library of Medicine. NCT06416072 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.