The Swedish BioFINDER 2 Study
BioFINDER2
1 other identifier
interventional
1,505
1 country
2
Brief Summary
The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g. to characterize the role of beta-amyloid pathology in early diagnosis of Alzheimer's disease (AD) using amyloid-PET (18F-Flutemetamol) and Aβ analysis in cerebrospinal fluid samples. The BioFINDER 1 study has resulted in more than 40 publications during the last three years, many in high impact journals, and some the of the results have already had important implications for the diagnostic work-up patients with AD in the clinical routine practice. The original BioFINDER 1 cohort started to include participants in 2008. Since then there has been a rapid development of biochemical and neuroimaging technologies which enable novel ways to the study biological processes involved in Alzheimer's disease in living people. There has also been a growing interest in the earliest stages of AD and other neurodegenerative diseases. With the advent of new tau-PET tracers there is now an opportunity to elucidate the role of tau pathology in the pathogenesis of AD and other tauopathies. The Swedish BioFINDER 2 study has been designed to complement the BioFINDER 1 study and to e.g. address issues regarding the role of tau pathology in different dementias and in preclinical stages of different dementia diseases. Further, the clinical assessments and MRI methods have been further optimized compared to BioFINDER 1. Detailed assessments of motor aspects and dual task performance, which is part of a sub-study named Motor-ACT: "Motor aspects and activities in relation to cognitive decline and brain pathologies, has been added to further optimize assessment of motor function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 28, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 27, 2025
April 1, 2025
11.6 years
May 28, 2017
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical diagnosis
Clinical diagnosis according to consensus group decision blinded to the diagnostic test
Clinical diagnosis at last 1 day visit
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Change in CDR-SB
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
Secondary Outcomes (4)
Rate of cognitive decline as measured by MMSE.
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
Rate of cognitive decline as measured in ADL-function.
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
Rate of volume change of structural MRI measures and amyloid PET
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
Rates of change on cerebrospinal fluid AD biomarkers
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
Study Arms (5)
COHORT A: Cognitively healthy younger individuals (40-65 y)
OTHERWe will recruit 300 cognitively healthy individuals from the Malmö Offspring study, which is an epidemiological study. The participants will be stratified according to a) family history of dementia in first degree relatives (with onset before 80 years of age) and b) APOE 4 genotype; i.e. 25% will have no family history and no APOE4 allele, 25% will have a family history and no APOE 4 allele, 25% will have no family history and at least one APOE 4 allele, 25% will have a family history and at least one APOE 4 allele. FOLLOW-UP FOR 8 YEARS Every 2 years new clinical, cognitive, neurological, and psychiatric assessments will be performed as well as CSF/blood sampling. MRI, Tau PET and Amyloid PET will be done every 4 years in all cases, and Tau PET and MRI every two years if the subject is amyloid positive at baseline. An auxiliary cohort (termed "Cohort A2") of 40 healthy individuals aged 20-40 years of age will also be included.
COHORT B: Cognitively healthy elderly individuals (66-100 y)
OTHERWe will recruit 300 cognitively healthy individuals from the Malmö/Lund region, where we will aim to include as many individuals as possible that did participate in the Malmö Diet and Cancer study during the early 1990's. The participants will be stratified according to a) family history of dementia in first degree relatives (with onset before 80 years of age) and b) APOE 4 genotype; i.e. 25% will have no family history and no APOE 4 allele, 25% will have a family history and no APOE 4 allele, 25% will have no family history and at least one APOE 4 allele, 25% will have a family history and at least one APOE 4 allele. FOLLOW-UP FOR 8 YEARS Every 2 years new clinical, cognitive, neurological, and psychiatric assessments will be performed as well as CSF/blood sampling. MRI, Tau PET and Amyloid PET will be done every 4 years in all cases, and Tau PET and MRI every two years if the subject is amyloid positive at baseline. Motor assessments (Motor-ACT) are performed at baseline and afte
COHORT C: SCD and MCI
OTHER\>750 patients with either subjective cognitive decline (SCD) or mild cognitive impairment (MCI) will be recruited in a consecutive fashion from the Skåne University Hospital and Ängelholm Hospital. We will only include cases where the medical doctor believes that the cognitive symptoms are caused by an incipient neurocognitive disorder. For example, cases with evidence of brain amyloid pathology (i.e. an abnormal CSF Aβ42/40 ratio). FOLLOW-UP FOR 6 YEARS Every 12 months new clinical, cognitive, neurological, and psychiatric assessments will be performed. CSF/blood sampling, Tau PET, Amyloid PET and MRI will be done every 2 years. Motor assessment (Motor-ACT) at year 1, year 3 and year 5. A auxiliary cohort ("Cohort C2") \>150 cases with SCD/MCI where the doctor does not suspect incipient neurocognitive disorder, will undergo the same baseline investigations, but they will be followed up clinically only after 2, 4 and 8 y. In total, 1000 patients with SCD or MCI will be included.
COHORT D: Dementia due to Alzheimer's disease
OTHER400 patients with mild to moderate dementia due to Alzheimer's disease (AD) will be recruited from the Skåne University Hospital and Ängelholm Hospital in southern Sweden. We will include at least 50 cases aged 40-65 years of age, at least 200 cases aged 66-79 years of age and at least 50 cases aged 80-100 years of age. FOLLOW-UP FOR 2 YEARS Every 12 months new clinical, cognitive, neurological, and psychiatric assessments will be performed. CSF/blood sampling, Tau PET and MRI will be done at baseline and after 2 years. Amyloid PET is performed at baseline for a subset of this group.
COHORT E: Other dementias
OTHERPatients with primary neurodegenerative disorders other than Alzheimer's disease will be recruited: 1. 160 cases with Frontotemporal dementia (FTD)-related disorders, including behavioral variant of FTD (bvFTD), Progressive nonfluent aphasia (PNFA), semantic dementia (SD), Progressive supranuclear palsy (PSP), Corticobasal degeneration (CBD). 2. 50 cases with subcortical Vascular dementia (VaD). 3. 200 cases with either Parkinson's disease (PD), Parkinson's disease with dementia (PDD), Dementia with Lewy Bodies (DLB), Multiple system atrophy (MSA). FOLLOW-UP FOR 2 YEARS Every 12 months new clinical, cognitive, neurological, and psychiatric assessments will be performed. CSF/blood sampling, Tau PET (depends on further funding) and MRI will be done at baseline and after 2 years. No Amyloid PET in this group. Motor assessments (Motor-ACT) are performed at baseline and a 2-year follow-up since 7th Oct 2019.
Interventions
PET imaging of Abeta amyloid
PET imaging of Tau aggregates
Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
- 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.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skane University Hospitallead
- Lund Universitycollaborator
Study Sites (2)
Memory Clinic, Hospital of Ängelholm
Ängelholm, SE-262 81, Sweden
Memory Clinic, Skåne University Hospital
Malmo, SE-20502, Sweden
Related Publications (1)
Cullen N, Janelidze S, Palmqvist S, Stomrud E, Mattsson-Carlgren N, Hansson O; Alzheimer's Disease Neuroimaging Initiative. Association of CSF Abeta38 Levels With Risk of Alzheimer Disease-Related Decline. Neurology. 2022 Mar 1;98(9):e958-e967. doi: 10.1212/WNL.0000000000013228. Epub 2021 Dec 22.
PMID: 34937781DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oskar Hansson, MD, Professor
Skåne University Hospital, and Lund University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
May 28, 2017
First Posted
June 5, 2017
Study Start
May 15, 2017
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 27, 2025
Record last verified: 2025-04