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The Swedish BioFINDER 2 Study

Study acronym: BioFINDER2
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment target: 1505 to 2950
    • Primary and study completion dates: Dec 31, 2028 to Dec 2036
    • Eligibility criteria expanded, about 1 word
    v7
  2. Minor Study description revisedv6
  3. Minor Study description expanded, about 59 wordsv5
  4. Minor Site details revised at 1 of 2 sitesv4
  5. Minor Study description expanded, about 2 wordsv3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,978 trials monitored
See 106 trials at risk
and 1 more disease
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 Details
NCT Number NCT03174938
Lead Sponsor Skane University Hospital
Collaborators: Lund University
Conditions
(from sponsor)
Dementia, Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Parkinson-Dementia Syndrome, Frontotemporal Degeneration, Semantic Dementia, Progressive Nonfluent Aphasia +5 more
Related terms Alzheimer Disease, Amyotrophic Lateral Sclerosis, Cognitive Dysfunction, Corticobasal Degeneration, Dementia, Disease, Frontotemporal Dementia, Lewy Body Disease, Multiple System Atrophy, Parkinson Disease, Pick Disease of the Brain, Primary Progressive Nonfluent Aphasia, Progressive supranuclear palsy atypical, Supranuclear Palsy, Progressive
Enrollment 2,950 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov