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

Active, not recruiting

• Conditions: Alzheimer's Disease
• Interventions: Other: No Intervention

• Registration Number: NCT06043700
• Lead Sponsor: Eisai Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	No Intervention	Participants with or without symptoms of AD will be enrolled and observed in this study.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Eisai Site #3; 🇺🇸 Clermont, Florida, United States

Eisai Site #1; 🇺🇸 Lady Lake, Florida, United States

Eisai Site #2; 🇺🇸 District Heights, Maryland, United States