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

Last updated: November 28, 2024
Sponsor: Eisai Limited
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Memory Loss

Alzheimer's Disease

Dementia

Treatment

No Intervention

Clinical Study ID

NCT06043700
R2000-G000-008
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 confirmedprior 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 previouspositron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing

  1. Provide written informed consent

  2. Willing and able to comply with all aspects of the protocol

  3. Willing to be referred to a clinical site if the assessment results meet thecriteria

Exclusion

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 Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
September 12, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Eisai Site #3

    Clermont, Florida 34711
    United States

    Site Not Available

  • Eisai Site #1

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Eisai Site #2

    Orlando, Florida 32801
    United States

    Site Not Available

  • Eisai Site #2

    District Heights, Maryland 20747
    United States

    Site Not Available

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