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Blood-based Biomarkers for Diagnosis of Alzheimer's

NCT05187819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-09-28

No results posted yet for this study

Summary

Alzheimer's disease (AD) may currently be diagnosed using molecular biomarkers in cerebrospinal fluid (CSF) and/or positron emission tomography (PET). These diagnostic procedures are highly accurate, but the high cost and low availability hamper their feasibility. Recently, ultrasensitive blood tests predicting Alzheimer pathologies in the brain have been developed. These tests have a reliable ability to differentiate AD from other neurodegenerative disorders and identify AD across the clinical continuum with high sensitivity and specificity in research cohorts with a high prevalence of AD.

This project will assess the predictive value of these tests in a general practice population.

The hypothesis is that the actual blood panel will have high positive predictive value for a diagnosis of Alzheimer's disease in the primary health care setting.

Conditions

  • Dementia Alzheimers

Interventions

DIAGNOSTIC_TEST

predictive value of a blood test

Evaluation of the clinical value of a new blood based test for diagnosis of Alzheimer's disease in a general practice population.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Svein Skeie, MD PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-12-31
Completion
2029-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187819 on ClinicalTrials.gov