The Swedish BioFINDER - Primary Care Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorSkane University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

1,200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Skane University Hospital

Lead sponsor

Lund University

Collaborator