The Swedish BioFINDER - Primary Care Study

Plain English Summary

The Swedish BioFINDER - Primary Care Study is a Not Applicable clinical trial sponsored by Skane University Hospital studying Mild Dementia, Mild Cognitive Impairment, SCD, Alzheimer Disease, Lewy Body Disease, Frontotemporal Degeneration, Vascular Dementia. This study tests new blood tests and brain imaging methods to help doctors in regular clinics better identify early signs of Alzheimer's disease and other cognitive impairments. It is for individuals experiencing memory or thinking changes, or those suspected by their doctor of having a progressive brain disorder. Participation involves undergoing cognitive tests, providing blood samples for biomarker analysis, and potentially brain imaging. Currently, diagnosis often relies on specialized clinics; this study seeks to bring more accurate diagnostic tools to your local doctor's office. The trial aims to enroll 1200 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 40 or older and are seeking medical help for changes in your thinking or memory, or if your doctor suspects a progressive brain condition. Individuals with subjective cognitive decline, mild cognitive impairment, or mild dementia are eligible. You cannot join if you already have a diagnosed dementia, have unstable serious illnesses, or are currently misusing alcohol or substances. People with cognitive issues caused by recent stroke, severe anemia, infection, sleep problems, psychosis, or severe depression may not be able to participate. This trial is studying Mild Dementia, Mild Cognitive Impairment, SCD, Alzheimer Disease, Lewy Body Disease, Frontotemporal Degeneration, Vascular Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well new blood tests and brain scans can accurately detect the underlying brain changes of Alzheimer's disease in people with early thinking problems. The specific primary outcome measures are: Presence of brain AD pathology as determined by CSF AD biomarkers (At baseline (cross-sectional)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to make diagnosing Alzheimer's disease and other cognitive issues easier and more accurate in everyday doctor's offices, filling a gap in early detection and referra This research targets Mild Dementia, Mild Cognitive Impairment, SCD, Alzheimer Disease, Lewy Body Disease, Frontotemporal Degeneration, Vascular Dementia, where improved treatment options are needed.

Investor Insight

This observational study focuses on improving diagnostic tools, which could lead to earlier treatment initiation and better patient management, potentially impacting a large market for dementia diagno The large enrollment target of 1200 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if these new diagnostic methods could help clarify your cognitive symptoms. Be prepared for appointments that may include cognitive assessments, blood draws, and possibly brain scans. Your participation will help doctors identify cognitive decline earlier and more accurately. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 1,200 participants

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.

Primary Outcomes

• Presence of brain AD pathology as determined by CSF AD biomarkers (At baseline (cross-sectional))

Secondary Outcomes

• Clinical diagnosis supported by CSF biomarkers (At baseline (cross-sectional))
• Presence of brain AD pathology as determined by amyloid PET imaging (At baseline (cross-sectional))
• Presence of brain AD pathology as determined by tau PET imaging (At baseline (cross-sectional))
• Rate of progression to AD dementia in patients with SCD or MCI at baseline (Follow-up over appr. 4 years)
• Change in patient management (At baseline (cross-sectional))

Full Eligibility Criteria

Inclusion Criteria:

1. 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.
2. The main symptom is usually memory complaints, but could also be executive, visuo-spatial, language, or attention complaints.
3. Age ≥40 years
4. Subjective cognitive decline, mild cognitive impairment or mild dementia

Exclusion Criteria:

1. Already diagnosed dementia
2. Significant unstable systemic illness or organ failure that makes it difficult to participate.
3. Current significant alcohol or substance misuse.
4. Refusing investigation at the Memory clinic
5. Cognitive impairment with acute onset due to stroke
6. 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.

Trial Locations

• Primary care centers in Region Skåne, Malmo, Sweden

Frequently Asked Questions

Related Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Mild Dementia
• Subjective Cognitive Decline (SCD)
• Lewy Body Disease
• Frontotemporal Degeneration
• Vascular Dementia
• Cognitive Impairment
• Neurodegenerative Disorders
• Memory Loss

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