A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology

March 4, 2026 updated by: Eisai Limited

A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology

The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clermont, Florida, United States, 34711
        • Eisai Site #3
      • Lady Lake, Florida, United States, 32159
        • Eisai Site #1
    • Maryland
      • District Heights, Maryland, United States, 20747
        • Eisai Site #2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with or without symptoms of AD will be screened in this study.

Description

Inclusion Criteria:

  1. Male or female, age 50 to 80 years inclusive, at the time of informed consent

    - Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:

    • First degree relative with dementia onset before age 75,
    • Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
    • Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
  2. Provide written informed consent
  3. Willing and able to comply with all aspects of the protocol
  4. Willing to be referred to a clinical site if the assessment results meet the criteria

Exclusion Criteria:

  1. Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
  2. Participation in an interventional clinical trial study at the time of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Participants with or without symptoms of AD will be enrolled and observed in this study.
Other: No Intervention
No treatment intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Low, Medium, and High Amyloid Pathology
Time Frame: At Screening on Day 1
Number of participants with low, medium, and high amyloid pathology will be estimated.
At Screening on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2000-G000-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on No Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe