RecruitingNot ApplicableNCT03174938

The Swedish BioFINDER 2 Study

Sponsor

Skane University Hospital

Enrollment

1,505 participants

Start Date

May 15, 2017

Study Type

INTERVENTIONAL

Conditions

Dementia Multiple System Atrophy Alzheimer Disease Parkinson Disease Corticobasal Degeneration Mild Cognitive Impairment Lewy Body Disease Progressive Supranuclear Palsy Frontotemporal Degeneration Semantic Dementia Parkinson-Dementia Syndrome Progressive Nonfluent Aphasia

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

Inclusion Criteria24

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.
Age 66-100 years
Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
MMSE score 26-30 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.
Age 40-100 years.
Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis, psychomotor or social cognitive complaints.
MMSE score of 24 - 30 points.
Do not fulfill the criteria for any dementia (major neurocognitive disorder) according to DSM-V.
The medical doctor (after clinical assessments, cognitive testing, CSF analyses and structural brain imaging) believes the cognitive complaints are caused by an incipient neurocognitive disorder of any sort. This is defined as any case fulfilling the criteria above (i.e. both SCD and MCI) with an abnormal CSF Aβ42/40 ratio, which is strongly associated with brain Aβ pathology and prodromal Alzheimer's disease. Further, cases with MCI (=minor neurocognitive impairment) due to either Parkinson's disease, Lewy body disease, vascular neurocognitive disorder or frontotemporal dementia (please see Appendix below for clinical criteria and references) can also be included.
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.
Age 40-100 years.
Referred to the memory clinics due to cognitive symptoms experienced by the patient and/or informant. These symptoms do not have to be memory complaints, but could also be executive, visuospatial, language, praxis or psychomotor complaints.
MMSE score of 12-26 points.
Fulfill the criteria for dementia (major neurocognitive disorder) due to Alzheimer's disease (DSM-V).
Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests.
Age 40-100 years.
Fulfill the criteria for dementia (major neurocognitive disorder) due to FTD, PDD, DLB or subcortical VaD alternatively the criteria for PD, PSP, MSA or CBS.
Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests.

Exclusion Criteria17

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.
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.
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.
Refusing lumbar puncture, MRI or PET.
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.
Refusing lumbar puncture, MRI or PET.
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.
Refusing lumbar puncture, MRI or PET.