The Swedish BioFINDER 2 Study

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.

Conditions

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

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

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Skane University Hospital

  lead OTHER

Principal Investigators

• Erik Stomrud, MD, Phd · Skåne University Hospital, and Lund University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-15

Primary Completion

2036-12-31

Completion

2036-12-31

Countries

• Sweden

Study Locations