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

Alzheimer's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043700
• Other study ID #: R2000-G000-008
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Eisai Inc.
• Contact: Eisai Medical Information
• Phone: +1-888-274-2378
• Email: esi_medinfo[@]eisai.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• No Intervention
No treatment intervention will be administered.

Locations

Country	Name	City	State
United States	Eisai Site #1	Lady Lake	Florida
United States	Eisai Site #2	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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