The Swedish BioFINDER - Primary Care Study

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. Improve the detection of mild cognitive impairment (MCI) and dementia in primary care.
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. To prospectively validate plasma AD biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in primary care.
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

Interventions

DIAGNOSTIC_TEST

Plasma APS 2 score

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.

DIAGNOSTIC_TEST

Plasma p-tau217/np-tau217

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

DIAGNOSTIC_TEST

Plasma p-tau217

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

DIAGNOSTIC_TEST

Plasma neurofilament light (NfL)

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

DIAGNOSTIC_TEST

Plasma Ab42/Ab40

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

DIAGNOSTIC_TEST

MRI and CT of the brain

Structural brain imaging

DIAGNOSTIC_TEST

Different cognitive tests

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

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Skane University Hospital

  lead OTHER

Principal Investigators

• Erik Stomrud, MD, PhD · Skane University Hospital and Lund University

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Sweden

Study Locations