| NCT ID | NCT03174938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skane University Hospital |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,950 participants |
| Start Date | 2017-05-15 |
| Primary Completion | 2036-12 |
Trial Parameters
Eligibility Fast-Check
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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.
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.