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Blood-based Biomarkers for Diagnosis of Alzheimer's

Primary Purpose

Dementia Alzheimers

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
predictive value of a blood test
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia Alzheimers focused on measuring Alzheimer's dementia, Diagnosis, Biomarkers, Clinical practice

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients where the GP suspects "dementia" (or disease leading to dementia).
  • Subjective cognitive decline, i.e. patient, an informant, or the clinician suspect decline of memory or other cognitive functioning.
  • Clinical evaluation is consistent with cognitive impairment, based on history, clinical examination or cognitive screening

Exclusion Criteria:

  • Severe dementia with lack of capacity for consent as judged by the GP.
  • Previously diagnosed dementia.
  • Major psychiatric disease, use of medication, or physical disease, which according to the GP may affect participation or likely contribute significantly to the observed cognitive impairment.
  • Patients who do not want to be referred to the memory outpatient clinic.

Sites / Locations

  • Stavanger University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 24, 2021
Last Updated
September 26, 2023
Sponsor
Helse Stavanger HF
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05187819
Brief Title
Blood-based Biomarkers for Diagnosis of Alzheimer's
Official Title
Accuracy of Blood-based Biomarkers in Diagnosing Alzheimer's Disease in Clinical Practice
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers
Keywords
Alzheimer's dementia, Diagnosis, Biomarkers, Clinical practice

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with positive blood test for biomarkers for Alzheimer's disease
Arm Type
Experimental
Arm Description
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)
Arm Title
Patients with negative blood test for biomarkers for Alzheimer's disease
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
predictive value of a blood test
Intervention Description
Evaluation of the clinical value of a new blood based test for diagnosis of Alzheimer's disease in a general practice population.
Primary Outcome Measure Information:
Title
The positive predictive value
Description
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Time Frame
2 years
Title
The negative predictive value
Description
The positive predictive value of the blood biomarkers for diagnosing Alzheimer's disease in general practice
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Svein R Kjosavik, MD PhD
Phone
+4790414252
Email
svein.kjosavik@sus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Anita L. Sunde, MD
Phone
+4746696494
Email
anita.lenora.sunde@sus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Skeie, MD PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4068
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Sunde, MD
Phone
46696494
Ext
+47
Email
anitalenora@gmail.com
First Name & Middle Initial & Last Name & Degree
Svein Kjosaviki, MD PhD
Phone
90414252
Ext
+47
Email
svein.kjosavik@sus.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood-based Biomarkers for Diagnosis of Alzheimer's

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