Study to Evaluate Amyloid in Blood and Imaging Related to Dementia

Alzheimer Disease Clinical Trial

— SEABIRD  

Official title:

Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899844
• Other study ID #: 201902081
• Status: Completed
• Start date: April 9, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET imaging, and an MRI.

Description:

Alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. Amyloid beta builds up in the brain and forms plaques in people with Alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. A blood test may be able to quickly and inexpensively screen people for Alzheimer's disease clinical trials and eventually diagnose Alzheimer's disease in the clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1122
• Est. completion date: January 31, 2024
• Est. primary completion date: January 29, 2024
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. At least 60 years of age

Exclusion Criteria:

1. Unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment.

2. Body weight of <100 pounds

3. Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)

4. Bleeding disorder

5. Taking an experimental drug for AD

6. Blood donation in the last two months

7. Blood transfusion in the last three months

8. On hospice

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia

Intervention

Other:
• Blood collection, PiB PET/MRI, and cognitive testing
Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma amyloid-beta 42/40 ratio		Baseline
Primary	Plasma amyloid-beta 42/40 ratio		6 months
Primary	Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status		6 months
Secondary	Coefficient of variation for the initial and confirmatory blood amyloid-beta test results		6 months