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

Eisai

Status: Invitation-only

Conditions: Alzheimer's Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06043700

R2000-G000-008

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

All Participants

Description:

Participants with or without symptoms of AD will be enrolled and observed in this study.

Treatment:

Other: No Intervention