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Alzheimer's Plasma Extension

NCT06416072 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-08-18

No results posted yet for this study

Summary

The goal of this observational study is to learn how Alzheimer's disease-related blood biomarkers, brain amyloid, and memory and thinking abilities change over time. The study will include up to 3,000 people who previously did not qualify for an anti-amyloid Alzheimer's disease prevention trial based on their amyloid eligibility. Participants may have previously screened for the AHEAD 3-45 Study, A4 Study, or another anti-amyloid Alzheimer's disease prevention trial.

The main questions this study aims to answer are:

* Can Alzheimer's disease-related blood tests help predict future buildup of amyloid in the brain?
* How are changes in Alzheimer's disease-related blood biomarkers related to changes in brain amyloid, memory, thinking, and self-reported cognitive function?
* Do these changes differ based on factors such as sex, APOE genetic status, race, ethnicity, socioeconomic status, or social factors?

Participants will be followed for about 6 years. They will complete memory and thinking assessments and questionnaires and provide blood samples. Some participants may also be asked to take part in optional activities, including brain imaging with positron emission tomography (PET) or magnetic resonance imaging (MRI), digital cognitive assessments, and questionnaires about habits and social factors.

Conditions

  • Preclinical Alzheimer's Disease
  • Alzheimer's Disease (AD)

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

  • National Institute on Aging (NIA)

    collaborator NIH

  • 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

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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