Status:
ENROLLING_BY_INVITATION
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
Lead Sponsor:
Eisai Limited
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Brief 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
- 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
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Willing to be referred to a clinical site if the assessment results meet the criteria
Exclusion
- Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
- Participation in an interventional clinical trial study at the time of consent
Key Trial Info
Start Date :
September 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06043700
Start Date
September 12 2023
End Date
September 30 2026
Last Update
November 26 2025
Active Locations (3)
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1
Eisai Site #3
Clermont, Florida, United States, 34711
2
Eisai Site #1
Lady Lake, Florida, United States, 32159
3
Eisai Site #2
District Heights, Maryland, United States, 20747