The Swedish BioFINDER 2 Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-100
SponsorSkane University Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

2,950 Participants
are divided into 5 treatment groups
Group A: COHORT A: Cognitively healthy younger individuals (40-65 y)Other 4 interventions
Group B: COHORT B: Cognitively healthy elderly individuals (66-100 y)Other 4 interventions
Group C: COHORT C: SCD and MCIOther 4 interventions
Group D: COHORT D: Dementia due to Alzheimer's diseaseOther 3 interventions
Group E: COHORT E: Other dementiasOther 3 interventions

Trial outcomes

Primary outcomes

1

Clinical diagnosis

Clinical diagnosis according to consensus group decision blinded to the diagnostic test

Time frame
Clinical diagnosis at last 1 day visit
2

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Change in CDR-SB

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.

Secondary outcomes

1

Rate of cognitive decline as measured by MMSE.

Mini Mental State Examination (MMSE)

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
2

Rate of cognitive decline as measured in ADL-function.

ADL function will be determined using the Functional Assessment Questionnaire (FAQ) and The Amsterdam ADL scale

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
3

Rate of volume change of structural MRI measures and amyloid PET

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
4

Rates of change on cerebrospinal fluid AD biomarkers

Time frame
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Skane University Hospital

Lead sponsor

Lund University

Collaborator