The Swedish BioFINDER 2 Study
Launched by SKANE UNIVERSITY HOSPITAL · Jun 2, 2017
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Swedish BioFINDER 2 study is a research project aimed at understanding different types of dementia, including Alzheimer's disease and related conditions. This study builds on previous research from the BioFINDER 1 study, focusing on the role of certain brain proteins that may contribute to the development of dementia. By using advanced imaging techniques and analyzing fluid samples from the brain, the study hopes to improve how we diagnose and understand these diseases, especially in their early stages.
If you or a loved one are between 40 and 100 years old and are interested in participating, there are specific eligibility criteria. For example, cognitively healthy individuals aged 40-100 can join if they show no signs of memory issues, while those with mild cognitive decline or diagnosed dementia may also be eligible. Participants will undergo evaluations like brain scans and tests to help researchers learn more about these conditions. The study is currently recruiting volunteers, and those interested should feel comfortable speaking and understanding Swedish, as this is essential for the study procedures.
Gender
ALL
Eligibility 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 or CBS.
- • 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.
About Skane University Hospital
Skåne University Hospital is a leading academic medical center located in Sweden, renowned for its commitment to advancing healthcare through innovative clinical research and trials. As a key player in the Nordic healthcare landscape, the hospital integrates cutting-edge medical practices with rigorous scientific inquiry, aiming to improve patient outcomes and foster advancements in medical knowledge. With a multidisciplinary approach, Skåne University Hospital collaborates with various stakeholders, including universities and research institutions, to conduct high-quality clinical trials that address critical health challenges and contribute to the development of new treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Malmö, , Sweden
ängelholm, , Sweden
Patients applied
Trial Officials
Oskar Hansson, MD, Professor
Principal Investigator
Skåne University Hospital, and Lund University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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