NCT03899844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,122

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

4.8 years

First QC Date

March 22, 2019

Last Update Submit

February 12, 2024

Conditions

Alzheimer DiseaseAlzheimer Dementia

Outcome Measures

Primary Outcomes (3)

  • Plasma amyloid-beta 42/40 ratio

    Baseline

  • Plasma amyloid-beta 42/40 ratio

    6 months

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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

Cognitively normal

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.

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

Cognitively impaired

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.

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

Interventions

Blood collection, PiB PET/MRI, and cognitive testingOTHER

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

Cognitively impairedCognitively normal

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.

You may qualify if:

  • \. At least 60 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Randall Bateman, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2019

First Posted

April 2, 2019

Study Start

April 9, 2019

Primary Completion

January 29, 2024

Study Completion

January 31, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available immediately following publication with no end date.
Access Criteria
Qualified researchers who provide a methodologically sound proposal will be able to access the data to achieve aims in the approved proposal. Proposals should be directed to batemanr@wustl.edu. To gain access, requestors will need to sign a data access agreement.

Locations

US(1)