A study on early diagnosis and biomarkers for dementia and related diseases
Official title: The Swedish BioFINDER 2 Study
Run by Skane University Hospital · NCT03174938 · Data updated 2026-11-12
This study is testing new ways to spot dementia and related diseases early by looking for specific markers in the brain and body, to help people at high risk and track how well new treatments are working.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 100 Years |
| Sex | All |
| Enrollment | 2950 (estimated) |
| Sponsor | Skane University Hospital Academic / other |
| Locations | 2 sites (Ängelholm and 1 other locations) |
| Status | Recruiting |
| Started | May 15, 2017 |
| Main results expected | December 2036 |
| Study ends | December 2036 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT03174938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include cognitively healthy individuals aged 40-100 who can understand Swedish and do not exhibit any cognitive symptoms.
✕Probably not a fit
Patients with significant neurological or psychiatric illnesses, or those who refuse necessary procedures like lumbar punctures or imaging, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Swedish BioFINDER 2 study aims to enhance early and accurate diagnosis of various dementia disorders, including Alzheimer's and Parkinson's diseases, by developing reliable biomarkers and advanced imaging techniques. This study builds on the previous BioFINDER 1 cohort and focuses on identifying patients at high risk for neurodegenerative diseases through minimally invasive methods. It also seeks to monitor the effects of new disease-modifying therapies using biomarkers that detect changes in brain pathology. Participants will undergo cognitive assessments, PET scans, and cerebrospinal fluid analysis to gather comprehensive data.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of dementia, improving patient outcomes and treatment options.
How similar studies have gone: Previous studies, including the original BioFINDER cohort, have shown success in developing biomarkers for Alzheimer's disease, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
COHORT A: Cognitively healthy younger individuals (40-65 years of age) INCLUSION CRITERIA * Age 40-65 years * Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders. * MMSE score 27-30 at screening visit. * Do not fulfill the criteria for MCI or any dementia according to DSM-V. * Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA * Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. * Current significant alcohol or substance misuse. * Significant neurological or psychiatric illness. * Refusing lumbar puncture, MRI or PET. COHORT B: Cognitively healthy elderly individuals (66-100 years of age) INCLUSION CRITERIA * Age 66-100 years * Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders. * MMSE score 26-30 at screening visit. * Do not fulfill the criteria for MCI or any dementia according to DSM-V. * Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA * Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. * Current significant alcohol or substance misuse. * Significant neurological or psychiatric illness. * Refusing lumbar puncture, MRI or PET. COHORT C: Subjective cognitive decline and mild cognitive impairment INCLUSION CRITERIA * Age 40-100 years. * Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis, psychomotor or social cognitive complaints. * MMSE score of 24 - 30 points. * Do not fulfill the criteria for any dementia (major neurocognitive disorder) according to DSM-V. * The medical doctor (after clinical assessments, cognitive testing, CSF analyses and structural brain imaging) believes the cognitive complaints are caused by an incipient neurocognitive disorder of any sort. This is defined as any case fulfilling the criteria above (i.e. both SCD and MCI) with an abnormal CSF Aβ42/40 ratio, which is strongly associated with brain Aβ pathology and prodromal Alzheimer's disease. Further, cases with MCI (=minor neurocognitive impairment) due to either Parkinson's disease, Lewy body disease, vascular neurocognitive disorder or frontotemporal dementia (please see Appendix below for clinical criteria and references) can also be included. * Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA * Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. * Current significant alcohol or substance misuse. * Refusing lumbar puncture, MRI or PET. COHORT D: Dementia due to Alzheimer's disease INCLUSION CRITERIA * Age 40-100 years. * Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis or psychomotor complaints. * MMSE score of 12-26 points. * Fulfill the criteria for dementia (major neurocognitive disorder) due to Alzheimer's disease (DSM-V). * Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA * Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. * Current significant alcohol or substance misuse. * Refusing lumbar puncture, MRI or PET. COHORT E: Other dementias INCLUSION CRITERIA * Age 40-100 years. * Fulfill the criteria for dementia (major neurocognitive disorder) due to FTD, PDD, DLB or subcortical VaD alternatively the criteria for PD, PSP, MSA, CBS or ALS. * Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests. EXCLUSION CRITERIA * Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study. * Current significant alcohol or substance misuse. * Refusing lumbar puncture, MRI or PET.
Where it's running
-
Memory Clinic, Hospital of Ängelholm
Ängelholm, Sweden Recruiting -
Memory Clinic, Skåne University Hospital
Malmö, Sweden Recruiting
Study contacts
- Principal investigator: Erik Stomrud, MD, Phd — Skåne University Hospital, and Lund University
- Study coordinator: Erik Stomrud, MD, PhD
- Email: erik.stomrud@med.lu.se
- Phone: +46 40 33 10 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.