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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06043700

Enrollment

2000

Registered

2023-09-21

Start date

2023-09-12

Completion date

2028-03-31

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

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

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.

Interventions

OTHERNo Intervention

No treatment intervention will be administered.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026