The Swedish BioFINDER 2 Study

Sponsor
Skane University Hospital
Study ID
NCT03174938
Status
Recruiting
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Conditions

  • ALS (Amyotrophic Lateral Sclerosis)
  • Alzheimer Disease
  • Corticobasal Degeneration
  • Dementia
  • Frontotemporal Degeneration
  • Lewy Body Disease
  • Mild Cognitive Impairment
  • Multiple System Atrophy
  • Parkinson Disease
  • Parkinson-Dementia Syndrome
  • Progressive Nonfluent Aphasia
  • Progressive Supranuclear Palsy
  • Semantic Dementia

Eligibility Criteria

Sex
ALL
Age
20 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Flutemetamol F18 Injection — DIAGNOSTIC_TEST
    PET imaging of Abeta amyloid
  • [18F]-RO6958948 — DIAGNOSTIC_TEST
    PET imaging of Tau aggregates
  • Elecsys (Roche) Abeta42, Ttau and Ptau — DIAGNOSTIC_TEST
    Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
  • Lumipulse (Fujirebio) Abeta42, Ttau and Ptau — DIAGNOSTIC_TEST
    Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid

Study Details

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.

Key Dates

First listed
Jun 5, 2017
Start date
May 15, 2017
Status verified
Apr 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
2,950 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: COHORT A: Cognitively healthy younger individuals (40-65 y)
    We 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.
  • Other: COHORT B: Cognitively healthy elderly individuals (66-100 y)
    We 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
  • Other: COHORT C: SCD and MCI
    \>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.
  • Other: COHORT D: Dementia due to Alzheimer's disease
    400 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.
  • Other: COHORT E: Other dementias
    Patients 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.

Primary Outcome Measure

Clinical diagnosis [ Time Frame: Clinical diagnosis at last 1 day visit ]

Central Contacts

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