Clinical amyloid test / Dementia / Clinical tau PET · Observational Study

Study to Understand Novel Biomarkers in Researching Dementia

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered observational cohort study currently enrolling participants to validate blood-based biomarkers (plasma amyloid-beta 42/40, p-tau217, %p-tau217) against amyloid and tau PET imaging and clinical diagnosis in Alzheimer's disease and mild cognitive impairment. No results are yet available in this registry record.

What was studied

Observational. Alzheimer Disease, Mild Cognitive Impairment, Dementia; age from 60 Years; accepts healthy volunteers. Intervention: Cognitively normal; Cognitively impaired. Compared with: Amyloid PET status, tau PET status, clinical diagnosis.. n = 1,800. 1 site: United States.

Key findings

Safety

This is a registry record with no results yet posted; no efficacy, accuracy, or safety data are available.

Who this may help

Once results are available, this study will evaluate whether blood biomarkers can replace or supplement invasive amyloid and tau PET imaging for diagnosis and prognosis of Alzheimer's disease. Clinicians should await publication of results before interpreting findings.

Plain-language summary

This is a recruiting observational study with no results posted; it is designed to evaluate novel blood biomarkers for dementia prediction but has not yet generated outcome data.

Study design

As stated by the source record.

MethodsCase Control model. Prospective time perspective. Primary outcome measures: Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status (assessed at Baseline); Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status (assessed at Baseline); Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status (assessed at Baseline); Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis (assessed at Baseline, 1 year, 2 years, 3 years, 4 years, 5 years); Area under the curve (AUC) of plasma amyloid-beta 42/40 in…

DesignObservational

PopulationAlzheimer Disease, Mild Cognitive Impairment, Dementia; age from 60 Years; accepts healthy volunteers

Sample size1,800

InterventionCognitively normal; Cognitively impaired

ComparatorAmyloid PET status, tau PET status, clinical diagnosis.

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size1800

Primary outcome measure 1Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status at baseline

Primary outcome measure 2Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status at baseline

Primary outcome measure 3Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status at baseline

Primary outcome measure 4Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis at baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Primary outcome measure 5Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis at baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Clinical bottom line

Caveats

This is a registry record with no results yet posted; no efficacy, accuracy, or safety data are available.
Study recruitment status is ongoing; follow-up data collection (up to 5 years) is not yet complete.
Geography, specific enrollment criteria, and detailed methods are not provided in this registry excerpt.
Effect sizes, confidence intervals, p-values, and comparative performance metrics are not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with planned longitudinal follow-up and diagnostic testing.

Directness

strong

Directly compares blood biomarkers to imaging and clinical outcomes in target population.

Consistency

insufficient

Registry record only; no results yet reported for consistency assessment.

Risk of bias

insufficient

Study is actively recruiting; conduct details and risk assessment not yet available.

Sample adequacy

strong

Planned enrollment of 1800 participants across multiple cognitive disease states.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06547099). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1800 participants (ESTIMATED). Conditions: Alzheimer Disease, Mild Cognitive Impairment, Dementia. Interventions: DIAGNOSTIC_TEST: Clinical tau PET; DIAGNOSTIC_TEST: Clinical amyloid test; OTHER: Research blood collection; OTHER: Cognitive assessments. Primary outcome measures: Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status , Baseline; Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status , Baseline; Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status , Baseline; Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis , 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 , Baseline, 1 year, 2 years, 3 years, 4 years, 5 years. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Clinical amyloid testDementiaClinical tau PETAlzheimer DiseaseWashington University School of MedicineCognitive assessmentsNCT06547099Mild Cognitive Impairment