The Swedish BioFINDER - Primary Care Study

NCT06120361 | Recruiting

• 1 other identifier: ADetect
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to improve the diagnostic accuracy of AD and cognitive impairment in primary care settings to ensure better care and treatment as well as facilitate correct referrals to specialized memory clinics. The investigators will strive to recruit diverse and representative populations of patients with subjective cognitive decline (SCD), mild cognitive impairment (MCI) and mild dementia. The specific aims of the study are to:

1. 1.Improve the detection of mild cognitive impairment (MCI) and dementia in primary care.
2. 2.Develop and evaluate cognitive tests, blood-based biomarkers and brain imaging methods that are suitable for accurate and early diagnosis of Alzheimer's disease (AD) in primary care.
3. 3.To prospectively validate plasma AD biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in primary care.
4. 4.Determine whether blood AD biomarkers improve patient management in primary care.

Conditions

Mild Dementia; Mild Cognitive Impairment; SCD; Alzheimer Disease; Lewy Body Disease; Frontotemporal Degeneration; Vascular Dementia

Keywords

Primary care, early diagnosis, blood, biomarkers, cognitive testing

Outcome Measures

Primary Outcomes (1)

• Presence of brain AD pathology as determined by CSF AD biomarkers

  CSF Ab42/Ab40 and p-tau217

  At baseline (cross-sectional)

Secondary Outcomes (6)

• Clinical diagnosis supported by CSF biomarkers

  At baseline (cross-sectional)

• Presence of brain AD pathology as determined by amyloid PET imaging

  At baseline (cross-sectional)

• Presence of brain AD pathology as determined by tau PET imaging

  At baseline (cross-sectional)

• Rate of progression to AD dementia in patients with SCD or MCI at baseline

  Follow-up over appr. 4 years

• Change in patient management

  At baseline (cross-sectional)

Study Arms (1)

Patients in primary care with cognitive symptoms

Diagnostic Test: Plasma APS 2 score; Diagnostic Test: Plasma p-tau217/np-tau217; Diagnostic Test: Plasma p-tau217; Diagnostic Test: Plasma neurofilament light (NfL); Diagnostic Test: Plasma Ab42/Ab40; Diagnostic Test: MRI and CT of the brain; Diagnostic Test: Different cognitive tests

Interventions

Plasma APS 2 score DIAGNOSTIC_TEST

APS 2 score (combination of ptau217/nptau217 and Ab42/Ab40). The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Patients in primary care with cognitive symptoms

Plasma p-tau217/np-tau217 DIAGNOSTIC_TEST

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Patients in primary care with cognitive symptoms

Plasma p-tau217 DIAGNOSTIC_TEST

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Patients in primary care with cognitive symptoms

Plasma neurofilament light (NfL) DIAGNOSTIC_TEST

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Patients in primary care with cognitive symptoms

Plasma Ab42/Ab40 DIAGNOSTIC_TEST

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

Patients in primary care with cognitive symptoms

MRI and CT of the brain DIAGNOSTIC_TEST

Structural brain imaging

Patients in primary care with cognitive symptoms

Different cognitive tests DIAGNOSTIC_TEST

Both standard paper-and-pen tests as well as digital cognitive tests will be evaluated.

Patients in primary care with cognitive symptoms

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will consecutively recruit 1200 patients seeking medical care due to mild cognitive symptoms in primary care units. They will be recruited at approximately 20-30 primary care facilities in Skåne. The patients will as usual first meet a general practitioner who performs a basic investigation of the patient to rule out other obvious causes causing the cognitive symptoms other than a dementia disorder, such as depression, sleep deprivation, etc. The patients, whose cognitive symptoms are not clearly explained by psychiatric or somatic conditions, will be assessed with cognitive tests by a dementia nurse or occupational therapist at the primary care unit.

You may qualify if:

• The patient seeks medical help because of cognitive symptoms experienced by the patient and/or informant OR The general practitioner suspects a progressive neurodegenerative disorder including, but not limited to, Alzheimer's disease, Lewy body disease, frontotemporal lobar degeneration or subcortical vascular cognitive impairment.
• The main symptom is usually memory complaints, but could also be executive, visuo-spatial, language, or attention complaints.
• Age ≥40 years
• Subjective cognitive decline, mild cognitive impairment or mild dementia

You may not qualify if:

• Already diagnosed dementia
• Significant unstable systemic illness or organ failure that makes it difficult to participate.
• Current significant alcohol or substance misuse.
• Refusing investigation at the Memory clinic
• Cognitive impairment with acute onset due to stroke
• The cognitive impairment can with certainty be explained by another condition or disease such as significant anemia, infection, severe sleep deprivation, psychotic disorder, moderate-severe depression, alcohol abuse etc.

Sponsors & Collaborators

• Skane University Hospital: lead
• Lund University: collaborator

Study Sites (1)

Primary care centers in Region Skåne

Malmo, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, CSF

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Sebastian Palmqvist, MD, PhD

CONTACT

+46-40-331000; Sebastian.Palmqvist@med.lu.se

Oskar Hansson, MD, PhD

CONTACT

+46-40-331000; oskar.hansson@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one year after study completion

Locations

SE (1)