Blood-based Biomarkers for Diagnosis of Alzheimer's

NCT05187819 | Recruiting

• 1 other identifier: 2730
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Alzheimers

Keywords

Alzheimer's dementia; Diagnosis; Biomarkers; Clinical practice

Outcome Measures

Primary Outcomes (2)

• The positive predictive value

  The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice

  2 years

• The negative predictive value

  The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice

  2 years

Study Arms (2)

Patients with positive blood test for biomarkers for Alzheimer's disease

EXPERIMENTAL

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)

Diagnostic Test: predictive value of a blood test

Patients with negative blood test for biomarkers for Alzheimer's disease

ACTIVE COMPARATOR

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)

Diagnostic Test: predictive value of a blood test

Interventions

predictive value of a blood test DIAGNOSTIC_TEST

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

Patients with negative blood test for biomarkers for Alzheimer's disease; Patients with positive blood test for biomarkers for Alzheimer's disease

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Svein Skeie, MD PhD

  Helse Stavanger HF

  STUDY DIRECTOR

Central Study Contacts

Svein R Kjosavik, MD PhD

CONTACT

+4790414252; svein.kjosavik@sus.no

Anita L. Sunde, MD

CONTACT

+4746696494; anita.lenora.sunde@sus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The results of the blood tests will be hidden for all involved until the investigation at the outpatients clinic is finished. Only the researchers will get the answers for the blood tests. The researchers will also get the results from investigation at the outpatient clinic, including test results of biomarkers in CSF.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A blood test will be taken from patients included. All included patients will have possible early dementia symptoms. A random sample of patients with negative and with positive blood-test results for actual biomarkers for Alzheimer's disease will be referred for further investigation at the memory outpatient clinic in Stavanger. The diagnosis from the memory clinic will be compared with the test results for the biomarkers, in order to calculate the positive and negative predictive value for these biomarkers in general practice.

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 12, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)