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

• Sponsor: Eisai Limited (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06043700
• Collaborator: (none)
• Enrollment: 2,000
• Locations: 2
• Anticipated Duration (Months): 18.6
• Patients Per Site: 1000
• Patients Per Site Per Month: 53.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Other: No Intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Sep 13, 2023
• Anticipated Primary Completion Date: Mar 31, 2025
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
All Participants Participants with or without symptoms of AD will be enrolled and observed in this study.	Other: No Intervention; No treatment intervention will be administered.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Low, Medium, and High Amyloid Pathology [At Screening on Day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. Provide written informed consent

2. Willing and able to comply with all aspects of the protocol

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eisai Site #1	Lady Lake	Florida	United States	32159
2	Eisai Site #2	Orlando	Florida	United States	32801

Sponsors and Collaborators

• Eisai Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Limited
• ClinicalTrials.gov Identifier: NCT06043700
• Other Study ID Numbers: R2000-G000-008
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eisai Limited: Alzheimers Disease; Blood-based biomarkers; Community-based screening
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Sep 21, 2023