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.
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
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
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.
Cohort
Prospective
Plasma APS 2 score
Diagnostic testAPS 2 score (combination of ptau217/nptau217 and Ab42/Ab40). The cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma p-tau217/np-tau217
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma p-tau217
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma neurofilament light (NfL)
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma Ab42/Ab40
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
MRI and CT of the brain
Diagnostic testStructural brain imaging
Different cognitive tests
Diagnostic testBoth standard paper-and-pen tests as well as digital cognitive tests will be evaluated.
Presence of brain AD pathology as determined by CSF AD biomarkers
CSF Ab42/Ab40 and p-tau217
Clinical diagnosis supported by CSF biomarkers
Clinical diagnosis based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) but supported by CSF biomarkers
Presence of brain AD pathology as determined by amyloid PET imaging
Amyloid PET imaging
Presence of brain AD pathology as determined by tau PET imaging
Tau PET imaging
Rate of progression to AD dementia in patients with SCD or MCI at baseline
Development of AD dementia during follow-up diagnosed using DSM-5 and supported by CSF biomarkers
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Skane University Hospital
Lead sponsor
Lund University
Collaborator
