RecruitingNCT06120361

The Swedish BioFINDER - Primary Care Study


Sponsor

Skane University Hospital

Enrollment

1,200 participants

Start Date

Jan 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • 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.

Interventions

DIAGNOSTIC_TESTPlasma 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_TESTPlasma p-tau217/np-tau217

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

DIAGNOSTIC_TESTPlasma p-tau217

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

DIAGNOSTIC_TESTPlasma neurofilament light (NfL)

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

DIAGNOSTIC_TESTPlasma Ab42/Ab40

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

DIAGNOSTIC_TESTMRI and CT of the brain

Structural brain imaging

DIAGNOSTIC_TESTDifferent cognitive tests

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


Locations(1)

Primary care centers in Region Skåne

Malmo, Sweden

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NCT06120361


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