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

Plain Language Summary

Simplified for easier understanding

This study, called the Swedish BioFINDER Primary Care Study, is investigating what early signs in the blood and brain can predict whether memory problems seen in primary care patients are due to Alzheimer's disease or another condition. Participants will undergo cognitive tests and biomarker measurements. **You may be eligible if...** - You are 40 years old or older - You are seeking medical care because you or someone close to you has noticed cognitive or memory problems - Your doctor suspects a possible neurodegenerative brain disease (such as Alzheimer's, Lewy body disease, or frontotemporal dementia) - You have mild cognitive decline, mild impairment, or early dementia **You may NOT be eligible if...** - You have already been diagnosed with dementia - Your cognitive decline started suddenly due to a stroke - You have a significant alcohol or substance misuse problem - Your cognitive problems can clearly be explained by another condition like severe depression, infection, or anemia - You are unwilling to attend a memory clinic for evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Malmö, Sweden

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NCT06120361


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