Study to Evaluate Amyloid in Blood and Imaging Related to Dementia

Completed

• Conditions: Alzheimer Dementia; Alzheimer Disease
• Interventions: Other: Blood collection, PiB PET/MRI, and cognitive testing

• Registration Number: NCT03899844
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2019-04-09
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1122

Inclusion Criteria

1. At least 60 years of age

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitively impaired	Blood collection, PiB PET/MRI, and cognitive testing	224 of the 1120 enrolled will exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI.
Cognitively normal	Blood collection, PiB PET/MRI, and cognitive testing	896 of the 1120 enrolled will not exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI.

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status	6 months
Plasma amyloid-beta 42/40 ratio	6 months

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results	6 months

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States