RecruitingNot ApplicableNCT03174938

The Swedish BioFINDER 2 Study


Sponsor

Skane University Hospital

Enrollment

2,950 participants

Start Date

May 15, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This long-term observational study (BioFINDER 2) is collecting brain scans, blood tests, and spinal fluid samples from healthy people and those with memory concerns to better understand and detect Alzheimer's disease and other brain conditions early. **You may be eligible if...** - You are between 40 and 100 years old, in one of several groups: cognitively healthy younger adults (40–65), healthy older adults (66–100), or those with mild cognitive impairment or dementia - You speak and understand Swedish without an interpreter - You are willing to undergo MRI, PET scans, or lumbar puncture as required **You may NOT be eligible if...** - You have a serious unstable illness or organ failure (e.g., terminal cancer) - You currently have significant alcohol or substance misuse problems - You have significant neurological or psychiatric illness (for healthy cohorts) - You refuse MRI, PET, or lumbar puncture procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFlutemetamol F18 Injection

PET imaging of Abeta amyloid

DIAGNOSTIC_TEST[18F]-RO6958948

PET imaging of Tau aggregates

DIAGNOSTIC_TESTElecsys (Roche) Abeta42, Ttau and Ptau

Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid

DIAGNOSTIC_TESTLumipulse (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

Malmö, Sweden

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NCT03174938


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