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Recruiting NCT06547099

Study to Understand Novel Biomarkers in Researching Dementia

— Observational Alzheimer Disease Mild Cognitive Impairment Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical tau PET, Clinical amyloid test, Research blood collection, Cognitive assessments.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Mild Cognitive Impairment, Dementia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis

Overview

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.

Detailed description

All participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. Depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for Alzheimer's disease as determined by the participant's medical provider.

Interventions

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

Primary outcome measures

  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status [Time frame: Baseline]
  • Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status [Time frame: Baseline]
  • Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status [Time frame: Baseline]
  • Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status [Time frame: Baseline]
  • Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status [Time frame: Baseline]
  • Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years]
  • Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years]
  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years]
  • Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis [Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years]

Eligibility criteria

Inclusion criteria

  • At least 60 years of age
  • 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and/or provider
  • All SEABIRD participants will be invited to participate regardless of their cognitive status

Exclusion criteria

  • Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment
  • Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection
  • Taking a disease-modifying drug for AD at time of enrollment
  • Blood transfusion in the last three months
  • Unwilling or unable to participate in all study activities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Publications

  • Li M, Li Y, Schindler SE, Yen D, Sutcliffe S, Babulal GM, Benzinger TLS, Lenze EJ, Bateman RJ. Design and feasibility of an Alzheimer's disease blood test study in a diverse community-based population. Alzheimers Dement. 2023 Dec;19(12):5387-5398. doi: 10.1002/alz.13125. Epub 2023 May 19. PMID 37204806
  • Janelidze S, Bali D, Ashton NJ, Barthelemy NR, Vanbrabant J, Stoops E, Vanmechelen E, He Y, Dolado AO, Triana-Baltzer G, Pontecorvo MJ, Zetterberg H, Kolb H, Vandijck M, Blennow K, Bateman RJ, Hansson O. Head-to-head comparison of 10 plasma phospho-tau assays in prodromal Alzheimer's disease. Brain. 2023 Apr 19;146(4):1592-1601. doi: 10.1093/brain/awac333. PMID 36087307
  • Janelidze S, Teunissen CE, Zetterberg H, Allue JA, Sarasa L, Eichenlaub U, Bittner T, Ovod V, Verberk IMW, Toba K, Nakamura A, Bateman RJ, Blennow K, Hansson O. Head-to-Head Comparison of 8 Plasma Amyloid-beta 42/40 Assays in Alzheimer Disease. JAMA Neurol. 2021 Nov 1;78(11):1375-1382. doi: 10.1001/jamaneurol.2021.3180. PMID 34542571

Identifiers

NCT: NCT06547099 · 202405156 · R01AG061900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗