Clinical trial NCT06547099: Study to Understand Novel Biomarkers in Researching Dementia
Official title: Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-08-09
Enrollment: 1800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who completed our prior study, the Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD, NCT03899844), will be invited to join SUNBIRD. We will also recruit approximately 1000 new participants from Washington University and Barnes-Jewish Hospital affiliated clinics in the greater St. Louis metropolitan area.

Brief summary: 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.

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

Primary outcomes:
measure: Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status
timeFrame: Baseline
measure: Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status
timeFrame: Baseline
measure: Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status
timeFrame: Baseline
measure: Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status
timeFrame: Baseline
measure: Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status
timeFrame: Baseline
measure: Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Randall Bateman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: David Carr, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.