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

NCT ID: NCT06043700

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-12

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

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

No Intervention

Intervention Type OTHER

No treatment intervention will be administered.

Interventions

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No Intervention

No treatment intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Site #3

Clermont, Florida, United States

Site Status

Eisai Site #1

Lady Lake, Florida, United States

Site Status

Eisai Site #2

District Heights, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R2000-G000-008

Identifier Type: -

Identifier Source: org_study_id

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