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

NCT06043700 | Active Not Recruiting

• 1 other identifier: R2000-G000-008
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimers Disease; Blood-based biomarkers; Community-based screening

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Low, Medium, and High Amyloid Pathology

  Number of participants with low, medium, and high amyloid pathology will be estimated.

  At Screening on Day 1

Study Arms (1)

All Participants

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

Other: No Intervention

Interventions

No Intervention OTHER

No treatment intervention will be administered.

All Participants

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (3)

Eisai Site #3

Clermont, Florida, 34711, United States

Location

Eisai Site #1

Lady Lake, Florida, 32159, United States

Location

Eisai Site #2

District Heights, Maryland, 20747, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual blood samples will be retained after obtaining consent from the participants and may be used for future biomarker assessment for AD.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (3)