NCT03174938RecruitingPhase 2
The Swedish BioFINDER 2 Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 2950 (estimated)
- First submitted
- 28 May 2017
- Start date
- 15 May 2017
- Primary completion date
- 31 Dec 2036
- Lead sponsor
- Skane University Hospital
- Diseases
- ALS (motor neurone disease), Frontotemporal dementia, Lewy body dementia, Alzheimer disease, Parkinson disease
- NCT number
- NCT03174938
- EU CT number
- 2024-511842-38-00
- EudraCT number
- 2017-000094-36
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 2950
- From 15 May 2017 to the primary completion date, 31 Dec 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Significant neurological or psychiatric illness.
- Absence of cognitive symptoms as assessed by a physician with special interest in cognitive disorders.
- Do not fulfill the criteria for MCI or any dementia according to DSM-V.
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Significant neurological or psychiatric illness.
- Refusing lumbar puncture, MRI or PET.
- COHORT C: Subjective cognitive decline and mild cognitive impairment INCLUSION CRITERIA
- 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.
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Refusing lumbar puncture, MRI or PET.
- COHORT D: Dementia due to Alzheimer's disease INCLUSION CRITERIA
- Fulfill the criteria for dementia (major neurocognitive disorder) due to Alzheimer's disease (DSM-V).
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- Fulfill the criteria for dementia (major neurocognitive disorder) due to FTD, PDD, DLB or subcortical VaD alternatively the criteria for PD, PSP, MSA, CBS or ALS.
- Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
Age
- Refusing lumbar puncture, MRI or PET.
- COHORT B: Cognitively healthy elderly individuals (66-100 years of age) INCLUSION CRITERIA
- Age 66-100 years
- Age 40-100 years.
- Age 40-100 years.
- Age 40-100 years.
Other
- Current significant alcohol or substance misuse.
- MMSE score 26-30 at screening visit.
- 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.
- Current significant alcohol or substance misuse.
- 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.
- 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.
- Current significant alcohol or substance misuse.
- 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.
- 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.
- Current significant alcohol or substance misuse.
- Refusing lumbar puncture, MRI or PET.
- COHORT E: Other dementias INCLUSION CRITERIA
- 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.
- Current significant alcohol or substance misuse.
- Refusing lumbar puncture, MRI or PET.
Criteria the registry did not label
- 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.
Age in the registry: 20 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skåne Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
Related publications
- Integration of plasma eMTBR-tau243 and p-tau217 in the diagnosis and stratification of Alzheimer's disease: a prospective cohort study.Lancet Neurol · 2026 · PMID 41864233
This page is information, not medical advice. Discuss any trial with your doctor.