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Completed

NCT Number: NCT03899844

Study to Evaluate Amyloid in Blood and Imaging Related to Dementia

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.

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Key information

Conditions

Alzheimer Disease Alzheimer Dementia Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 60 years of age

Exclusion criteria

  • 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.
  • Body weight of <100 pounds
  • Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)
  • Bleeding disorder
  • Taking an experimental drug for AD
  • Blood donation in the last two months
  • Blood transfusion in the last three months
  • On hospice

Treatment and study plan

Blood collection, PiB PET/MRI, and cognitive testing

Other

Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status.

Primary outcomes

  1. Plasma amyloid-beta 42/40 ratio

    Time frame: Baseline

  2. Plasma amyloid-beta 42/40 ratio

    Time frame: 6 months

  3. Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status

    Time frame: 6 months

Secondary outcomes

  1. Coefficient of variation for the initial and confirmatory blood amyloid-beta test results

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: SEABIRD

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2019
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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