Study to Understand Novel Biomarkers in Researching Dementia

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06547099
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clinical tau PET — DIAGNOSTIC_TEST
    Tau PET (flortaucipir)
  • Clinical amyloid test — DIAGNOSTIC_TEST
    Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
  • Research blood collection — OTHER
    Research blood assays for amyloid, tau, and neurodegeneration
  • Cognitive assessments — OTHER
    Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)

Study Details

The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.

Key Dates

Start date
Aug 14, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,800 participants (estimated)

Arms

  • Arm: Cognitively normal
    Participants without symptoms of cognitive impairment will be followed up annually for potential cognitive changes, and will complete additional blood collections every two years.
  • Arm: Cognitively impaired
    For participants with symptoms of cognitive impairment, their medical providers will review the results of the research cognitive assessments and determine whether further testing (a clinical tau PET scan and choice of an amyloid PET, cerebrospinal fluid, or blood clinical test for amyloid plaques) is needed. Symptomatic participants will be followed up annually for research blood collections and cognitive assessments.

Primary Outcome Measure

Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Lisa Soke
[email protected]
314-747-4857
Randall Bateman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Washington University School of Medicine· St Louis, MO

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