MedTrace Logo

Alzheimer's Plasma Extension

NCT06416072 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-10

No results posted yet for this 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

  • Preclinical Alzheimer's Disease
  • Early Preclinical Alzheimer's Disease

Interventions

RADIATION

NAV4694

Amyloid PET imaging with NAV4694 injection

Sponsors & Collaborators

  • Alzheimer's Clinical Trials Consortium (ACTC)

    collaborator UNKNOWN

  • Alzheimer's Therapeutic Research Institute

    collaborator OTHER

  • Alzheimer's Association

    collaborator OTHER

  • University of Southern California

    lead OTHER

Principal Investigators

  • Paul Aisen, MD · University of Southern California (USC) Alzheimer's Therapeutic Research Institute (ATRI)

  • Reisa Sperling, MD · Brigham and Women's Hospital and Massachusetts General Hospital

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06416072 on ClinicalTrials.gov