The Swedish BioFINDER 2 Study (NCT03174938) | Clinical Trial Compass
RecruitingNot Applicable
The Swedish BioFINDER 2 Study
Sweden2,950 participantsStarted 2017-05-15
Plain-language 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.
Who can participate
Age range
20 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Signific…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical diagnosis
Timeframe: Clinical diagnosis at last 1 day visit
2
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Timeframe: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.