Blood-based Biomarkers for Diagnosis of Alzheimer's
ConditionDementia Alzheimers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-100
SponsorHelse Stavanger HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants suspected by their GP to have possible dementia, based on history, clinical examination and/or cognitive screening
Disqualifiers
Lack of capacity for consent as judged by the GP.
Severe psychiatric disease, use of medication or physical disease that according to the GP may affect participation or likely contribute significantly to the observed cognitive impairment.
Patients not wanting to be referred to the memory outpatient clinic.
Trial design
Design model
Parallel
Treatments tested in this trial
predictive value of a blood test
Diagnostic testEvaluation of the clinical value of a new blood based test for diagnosis of Alzheimer's disease in a general practice population.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Patients with positive blood test for biomarkers for Alzheimer's diseaseExperimental treatment 1 intervention
Group B: Patients with negative blood test for biomarkers for Alzheimer's diseaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The positive predictive value
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Time frame
2 years2
The negative predictive value
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helse Stavanger HF
Lead sponsor
Sahlgrenska University Hospital
Collaborator
Source ClinicalTrials.gov