Dementia AlzheimersNCT05187819
Blood-based Biomarkers for Diagnosis of Alzheimer's
A study testing predictive value of a blood test in people with Dementia Alzheimers, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- predictive value of a blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants suspected by their GP to have possible dementia, based on history, clinical examination and/or cognitive screening
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital
Stavanger, 4068
Anita Sunde, MD, 46696494 ext. +47, anitalenora@gmail.com
Svein Kjosaviki, MD PhD, 90414252 ext. +47, svein.kjosavik@sus.no
About this study
Official title: Accuracy of Blood-based Biomarkers in Diagnosing Alzheimer's Disease in Clinical Practice
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.
Read the detailed description
A correct diagnosis of dementia is important in order to provide the patient and relatives with right information, and to give adequate treatment and support, but also to improve research and further development of treatment. Alzheimer's disease (AD) is the cause of nearly 2/3 of cases of dementia. Current diagnostic methods to ensure accurate diagnosis include analysis of cerebrospinal fluid and molecular PET, but these methods are expensive and not widely available.
Progress has been made in the development of blood-based diagnostic biomarkers for Alzheimer's disease. It will lead to significant simplification and improvement of clinical practice if simple blood tests that can be taken in general practice can provide a reliable diagnosis of Alzheimer's disease.
Several biomarkers (including phosphorylated tau 181, phosphorylated tau 217, phosphorylated tau 231, plasma glial fibrillary acidic protein, plasma β-amyloid 42 to β-amyloid 40 ratio, and plasma neurofilament light) has documented to be useful to distinguish Alzheimer's dementia from non-Alzheimer's dementia in research cohorts with a high prevalence of AD. This project aims to analyze the diagnostic ability of such biomarkers in a primary care cohort with a lower prevalence of AD.
The Stavanger region in Norway will be the catchment area for recruitment of study participants. The region is geographically distinct with 373,000 inhabitants, 15 municipalities with 320 GPs in 94 clinics, all served by one hospital. Consequently, the region offers unique opportunities for community-wide implementation research.
All General Practitioners (GPs) in the region will be invited to, upon consent, select participants for the study. To reflect real-life medical practice in primary care, broad inclusion criteria have been chosen. Blood samples will be taken at the GP offices. First, the robustness of the samples regarding temperature, time and transportation to the laboratory will be studied. Second, the results of the blood samples will be compared with the results of standard diagnostic procedures at the memory outpatient clinic at the hospital. A random sample of an equal number of patients with positive and negative blood biomarker test-results will undergo blinded specialist examination, including MRIs of the brain and analysis of the cerebrospinal fluid for Alzheimer biomarkers. The diagnosis made by the specialists will then be compared to the blood-test results in order to estimate the positive and negative predictive value of such biomarkers for the diagnosis of AD in general practice.
- Conditions
- Dementia Alzheimers
- Being tested
- predictive value of a blood test
- Keywords
- Alzheimer's dementia, Diagnosis, Biomarkers, Clinical practice
- Medical subject headings
- Alzheimer Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predictive value of a blood testDiagnostic test
Evaluation of the clinical value of a new blood based test for diagnosis of Alzheimer's disease in a general practice population.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Diagnostic Test: predictive value of a blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive predictive value
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Measured: 2 years
The negative predictive value
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Svein Skeie, MD PhD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187819
- Sponsor's protocol ID
- 2730
- Status last verified
- Sep 2023
- First submitted
- 24 Dec 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Blood-based Biomarkers in Diagnosing Alzheimer's Disease in Clinical Practice
- ClinicalTrials.gov ID
- NCT05187819
- Acronym / sponsor ID
- 2730
- Conditions
- Dementia Alzheimers
- Keywords
- Alzheimer's dementia, Diagnosis, Biomarkers, Clinical practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A correct diagnosis of dementia is important in order to provide the patient and relatives with right information, and to give adequate treatment and support, but also to improve research and further development of treatment. Alzheimer's disease (AD) is the cause of nearly 2/3 of cases of dementia. Current diagnostic methods to ensure accurate diagnosis include analysis of cerebrospinal fluid and molecular PET, but these methods are expensive and not widely available.
Progress has been made in the development of blood-based diagnostic biomarkers for Alzheimer's disease. It will lead to significant simplification and improvement of clinical practice if simple blood tests that can be taken in general practice can provide a reliable diagnosis of Alzheimer's disease.
Several biomarkers (including phosphorylated tau 181, phosphorylated tau 217, phosphorylated tau 231, plasma glial fibrillary acidic protein, plasma β-amyloid 42 to β-amyloid 40 ratio, and plasma neurofilament light) has documented to be useful to distinguish Alzheimer's dementia from non-Alzheimer's dementia in research cohorts with a high prevalence of AD. This project aims to analyze the diagnostic ability of such biomarkers in a primary care cohort with a lower prevalence of AD.
The Stavanger region in Norway will be the catchment area for recruitment of study participants. The region is geographically distinct with 373,000 inhabitants, 15 municipalities with 320 GPs in 94 clinics, all served by one hospital. Consequently, the region offers unique opportunities for community-wide implementation research.
All General Practitioners (GPs) in the region will be invited to, upon consent, select participants for the study. To reflect real-life medical practice in primary care, broad inclusion criteria have been chosen. Blood samples will be taken at the GP offices. First, the robustness of the samples regarding temperature, time and transportation to the laboratory will be studied. Second, the results of the blood samples will be compared with the results of standard diagnostic procedures at the memory outpatient clinic at the hospital. A random sample of an equal number of patients with positive and negative blood biomarker test-results will undergo blinded specialist examination, including MRIs of the brain and analysis of the cerebrospinal fluid for Alzheimer biomarkers. The diagnosis made by the specialists will then be compared to the blood-test results in order to estimate the positive and negative predictive value of such biomarkers for the diagnosis of AD in general practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with positive blood test for biomarkers for Alzheimer's disease | Experimental | Diagnostic Test: predictive value of a blood testThe 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) |
| Patients with negative blood test for biomarkers for Alzheimer's disease | Active comparator | Diagnostic Test: predictive value of a blood testThe 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) |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants suspected by their GP to have possible dementia, based on history, clinical examination and/or cognitive screening
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| predictive value of a blood testEvaluation of the clinical value of a new blood based test for diagnosis of Alzheimer's disease in a general practice population. | Diagnostic test | Patients with negative blood test for biomarkers for Alzheimer's disease, Patients with positive blood test for biomarkers for Alzheimer's disease |
Primary outcome
The positive predictive value
Time frame: 2 years
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
The negative predictive value
Time frame: 2 years
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svein Skeie, MD PhD study director
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing predictive value of a blood test in people with Dementia Alzheimers, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Svein R Kjosavik, MD PhD (+4790414252, svein.kjosavik@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive predictive value (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.