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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Site #3, Clermont, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

No intervention

Other

No treatment intervention will be administered.

Primary outcomes

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

Time frame: At Screening on Day 1

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

Sponsors and collaborators

Lead sponsor

Eisai Limited

Industry

Registry information

Official study title

A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Sep 21, 2023
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting