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Dementia
+11

The Swedish BioFINDER 2 Study

Sponsored by Skane University Hospital

About this trial

Last updated 2 years ago

Study ID

BioFINDER 2

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
20 to 100 Years
All
All

Trial Timing

Started 8 years ago

What is this trial about?

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.

What are the Participation Requirements?

COHORT A: Cognitively healthy younger individuals (40-65 years of age) INCLUSION CRITERIA

- 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.

EXCLUSION CRITERIA

- 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.

COHORT B: Cognitively healthy elderly individuals (66-100 years of age) INCLUSION
CRITERIA

- 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.

EXCLUSION CRITERIA

- 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.

COHORT C: Subjective cognitive decline and mild cognitive impairment INCLUSION CRITERIA

- 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.

EXCLUSION CRITERIA

- 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.

COHORT D: Dementia due to Alzheimer's disease INCLUSION CRITERIA

- 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.

EXCLUSION CRITERIA

- 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.

COHORT E: Other dementias INCLUSION CRITERIA

- 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 CRITERIA

- 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.

Locations

Location

Status

Recruiting
Recruiting