The Swedish BioFINDER - Memory Clinic Study
New blood test aims to improve dementia diagnosis accuracy
Plain English Summary
The Swedish BioFINDER - Memory Clinic 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 biomarkers to see if they can accurately diagnose memory loss and dementia, potentially replacing more invasive tests. It is for individuals being evaluated for memory problems or cognitive decline at a specialized memory clinic. Participation involves providing blood and cerebrospinal fluid samples, which will be analyzed and compared to current diagnostic methods. Currently, diagnosis can be challenging, with up to 30% of patients not receiving a correct diagnosis without advanced tests. The trial aims to enroll 1200 participants.
Official Summary
The diagnosis of diseases causing memory difficulties or dementia is often challenging. Without the use of advanced methods such as cerebrospinal fluid tests, approximately 25-30% do not receive a correct diagnosis today. However, the investigators have recently developed new blood biomarkers with high diagnostic accuracy, and the investigators now want to investigate whether they can eventually replace cerebrospinal fluid tests. This is because blood tests are much more cost-effective and significantly easier for patients compared to cerebrospinal fluid tests. In this study, 1200 patients undergoing clinical evaluations at the Memory Clinic, Skåne University Hospital in Malmö, are included for blood and cerebrospinal fluid sample collection. The blood samples are sent for analysis using the new blood biomarkers. Subsequently, the results are compared with those from the clinical analysis of cerebrospinal fluid to determine how well they perform in routine clinical practice as an alternative to cerebrospinal fluid tests and whether the blood test improves patient care. This comparison is carried out by the attending physician in three steps: 1. Assessment without access to the results of either the blood test or cerebrospinal fluid test. 2. Assessment with access to only the results of the blood test. 3. Assessment with access to the results of both the blood test and cerebrospinal fluid test. Aim 1) To prospectively validate plasma Alzheimer's disease (AD) biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in a specialist memory clinic. Aim 2) Determine whether blood AD biomarkers improve patient management in specialist memory clinic settings.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are currently being evaluated for memory or cognitive symptoms at a memory clinic. You must be scheduled to have cerebrospinal fluid and blood drawn as part of your regular clinical care. You cannot join if you are not scheduled for these specific tests as part of your clinical evaluation. 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 the new blood test identifies brain changes related to Alzheimer's disease, aiming for a diagnosis as accurate as current spinal fluid tests. The specific primary outcome measures are: 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 seeks to validate a simpler, less invasive blood test for diagnosing dementia, addressing a significant challenge in current memory disorder evaluations. 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 trial signals a significant market opportunity for more accessible and cost-effective dementia diagnostics, potentially improving patient care and reducing healthcare burdens. The large enrollment target of 1200 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this blood test could be a less invasive alternative to spinal fluid tests for your diagnosis. Your participation involves routine blood and spinal fluid collection, with no additional procedures required beyond your planned clinical evaluation. The study will compare diagnostic accuracy with and without the blood test results to see how it impacts your doctor's assessment. 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 Amyloid Probability Score 2 (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 ptau217/nptau217 — The cut off will be predefined. The samples will be analysed prospectively every two weeks.
- DIAGNOSTIC_TEST: Plasma ptau217 — 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
- 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))
- Brain AD pathology as determined by amyloid amyloid PET imaging (At baseline (cross-sectional))
- Brain AD pathology as determined by tau PET imaging (At baseline (cross-sectional))
- Progression to AD dementia in patients with SCD or MCI at baseline (At baseline (cross-sectional))
- Change in patient management (At baseline (cross-sectional))
Full Eligibility Criteria
Inclusion Criteria: 1. Under investigation for cognitive symptoms at the Memory clinic. 2. Cerebrospinal fluid and blood sampling is planned to be done as part of clinical practice even if the patient is not taking part of this study. Exclusion Criteria: 1. Not undergoing CSF or blood sampling as part of clinical practice. 2. Not undergoing cognitive testing as part of clinical practice.
Trial Locations
- Skåne University Hospital, Malmo, Sweden
Frequently Asked Questions
What is clinical trial NCT06122415?
NCT06122415 is a Not Applicable OBSERVATIONAL study titled "The Swedish BioFINDER - Memory Clinic Study." It is currently recruiting and is sponsored by Skane University Hospital. The trial targets enrollment of 1200 participants.
What conditions does NCT06122415 study?
This trial investigates treatments for Mild Dementia, Mild Cognitive Impairment, SCD, Alzheimer Disease, Lewy Body Disease, Frontotemporal Degeneration, Vascular Dementia. The primary condition under study is Mild Dementia.
What treatments are being tested in NCT06122415?
The interventions being studied include: Plasma Amyloid Probability Score 2 (APS 2) score (DIAGNOSTIC_TEST), Plasma ptau217/nptau217 (DIAGNOSTIC_TEST), Plasma ptau217 (DIAGNOSTIC_TEST), Plasma neurofilament light (NfL) (DIAGNOSTIC_TEST), Plasma Ab42/Ab40 (DIAGNOSTIC_TEST). 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.
What does Not Applicable mean for NCT06122415?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06122415?
This trial is currently "Recruiting." It started on 2022-12-01. The estimated completion date is 2026-12-31.
Who is sponsoring NCT06122415?
NCT06122415 is sponsored by Skane University Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06122415?
The trial aims to enroll 1200 participants. The trial is currently recruiting and accepting new participants.
How is NCT06122415 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06122415?
The primary outcome measures are: Brain AD pathology as determined by CSF AD biomarkers (At baseline (cross-sectional)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06122415 being conducted?
This trial is being conducted at 1 site, including Malmo (Sweden).
Where can I find official information about NCT06122415?
The official record for NCT06122415 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06122415. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06122415 testing in simple terms?
This study tests new blood biomarkers to see if they can accurately diagnose memory loss and dementia, potentially replacing more invasive tests. It is for individuals being evaluated for memory problems or cognitive decline at a specialized memory clinic.
Why is this trial significant?
This trial matters because it seeks to validate a simpler, less invasive blood test for diagnosing dementia, addressing a significant challenge in current memory disorder evaluations.
What are the potential risks of participating in NCT06122415?
The main risk is that the new blood test may not be as accurate as current methods, leading to a delayed or incorrect diagnosis. Potential side effects are related to the standard blood draw and cerebrospinal fluid collection, such as bruising, discomfort, or headache. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06122415?
Ask your doctor if this blood test could be a less invasive alternative to spinal fluid tests for your diagnosis. Your participation involves routine blood and spinal fluid collection, with no additional procedures required beyond your planned clinical evaluation. The study will compare diagnostic accuracy with and without the blood test results to see how it impacts your doctor's assessment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06122415 signal from an investment perspective?
This trial signals a significant market opportunity for more accessible and cost-effective dementia diagnostics, potentially improving patient care and reducing healthcare burdens. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood and cerebrospinal fluid samples, which will be analyzed and compared to current diagnostic methods. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.