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RECRUITING
NCT03174938
NA

The Swedish BioFINDER 2 Study

Sponsor: Skane University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

20 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

2950

Start Date

2017-05-15

Completion Date

2036-12

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Flutemetamol F18 Injection

PET imaging of Abeta amyloid

DIAGNOSTIC_TEST

[18F]-RO6958948

PET imaging of Tau aggregates

DIAGNOSTIC_TEST

Elecsys (Roche) Abeta42, Ttau and Ptau

Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid

DIAGNOSTIC_TEST

Lumipulse (Fujirebio) Abeta42, Ttau and Ptau

Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid

Locations (2)

Memory Clinic, Hospital of Ängelholm

Ängelholm, Sweden

Memory Clinic, Skåne University Hospital

Malmo, Sweden