Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD)

The Washington University

Status: Completed

Conditions: Alzheimer Dementia; Alzheimer Disease

Treatments: Other: Blood collection, PiB PET/MRI, and cognitive testing

Study type: Observational

Funder types: Other

Identifiers

NCT03899844

201902081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,122 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,122 participants in 2 patient groups

Cognitively normal

Description:

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.

Treatment:

Other: Blood collection, PiB PET/MRI, and cognitive testing

Cognitively impaired

Description:

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.

Treatment:

Other: Blood collection, PiB PET/MRI, and cognitive testing