NCT05187819 Blood-based Biomarkers for Diagnosis of Alzheimer's
| NCT ID | NCT05187819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helse Stavanger HF |
| Condition | Dementia Alzheimers |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Participants suspected by their GP to have possible dementia, based on history, clinical examination and/or cognitive screening Exclusion Criteria: * 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.
Contact & Investigator
Svein Skeie, MD PhD
STUDY DIRECTOR
Helse Stavanger HF
Frequently Asked Questions
Who can join the NCT05187819 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 100 Years, studying Dementia Alzheimers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05187819 currently recruiting?
Yes, NCT05187819 is actively recruiting participants. Contact the research team at svein.kjosavik@sus.no for enrollment information.
Where is the NCT05187819 trial being conducted?
This trial is being conducted at Stavanger, Norway.
Who is sponsoring the NCT05187819 clinical trial?
NCT05187819 is sponsored by Helse Stavanger HF. The principal investigator is Svein Skeie, MD PhD at Helse Stavanger HF. The trial plans to enroll 300 participants.
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