Accuracy of Blood-based Biomarkers in Diagnosing Alzheimer's Disease in Clinical Practice

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 100
Healthy Volunteers: f
View:

• Participants suspected by their GP to have possible dementia, based on history, clinical examination and/or cognitive screening

Locations
Other Locations
Norway
Stavanger University Hospital
RECRUITING
Stavanger
Contact Information
Primary
Svein R Kjosavik, MD PhD
svein.kjosavik@sus.no
+4790414252
Backup
Anita L. Sunde, MD
anita.lenora.sunde@sus.no
+4746696494
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Patients with positive blood test for biomarkers for Alzheimer's disease
The positive blood tests results for this group will be compared with the results from the investigation at the at the memory outpatient clinic to calculate the number of false positive blood tests (using the results from the outpatient clinic as a gold standard for the diagnosis)
Active_comparator: Patients with negative blood test for biomarkers for Alzheimer's disease
The negative blood tests results for this group will be compared with the results from the investigation at the at the memory outpatient clinic to calculate the number of false negative blood tests (using the results from the outpatient clinic as a gold standard for the diagnosis)
Related Therapeutic Areas
Sponsors
Leads: Helse Stavanger HF
Collaborators: Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov