The Swedish BioFINDER 2 Study

Plain English Summary

The Swedish BioFINDER 2 Study is a Not Applicable clinical trial sponsored by Skane University Hospital studying Dementia, Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Parkinson-Dementia Syndrome, Frontotemporal Degeneration, Semantic Dementia, Progressive Nonfluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration. This study tests advanced imaging and fluid tests to understand dementia, including Alzheimer's disease. It is for individuals experiencing cognitive changes, those with diagnosed dementia, and cognitively healthy people aged 40-100. Participation involves cognitive tests, brain scans (PET, MRI), and spinal fluid collection. Currently, there are no direct alternative treatments being tested within this observational study; standard care and diagnostic approaches are the alternatives. The trial aims to enroll 2950 participants.

Official 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

Here is what you need to know about eligibility for this trial. You may be eligible if you are between 40 and 100 years old and are experiencing cognitive symptoms, have a diagnosis of dementia, or are cognitively healthy. You cannot join if you have significant unstable health issues, current substance misuse, or significant neurological/psychiatric conditions. A key requirement is the ability to understand Swedish without an interpreter, and willingness to undergo PET scans, MRI, and lumbar puncture. This trial is studying Dementia, Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Parkinson-Dementia Syndrome, Frontotemporal Degeneration, Semantic Dementia, Progressive Nonfluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how accurately a clinical diagnosis is made and track the overall severity of cognitive impairment using the CDR-SB scale, helping to understand disease progression over t The specific primary outcome measures are: Clinical diagnosis (Clinical diagnosis at last 1 day visit); Clinical Dementia Rating-Sum of Boxes (CDR-SB) (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is crucial for advancing the early diagnosis and understanding of various dementias, including Alzheimer's, by exploring new biomarkers and imaging techniques to fill gaps in current diagno This research targets Dementia, Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Parkinson-Dementia Syndrome, Frontotemporal Degeneration, Semantic Dementia, Progressive Nonfluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration, where improved treatment options are needed.

Investor Insight

This study represents a significant investment in understanding neurodegenerative diseases, with potential to impact diagnostic markets and competitive landscapes for Alzheimer's and other dementias, The large enrollment target of 2950 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific types of dementia being investigated and what the results of the scans and tests might mean for you. Be prepared for multiple visits over several years, involving cognitive assessments, brain imaging (PET, MRI), and a spinal fluid sample collection. Understand that this is a research study focused on diagnosis and understanding, not a treatment trial. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 2,950 participants

Interventions

• DIAGNOSTIC_TEST: Flutemetamol F18 Injection — PET imaging of Abeta amyloid
• DIAGNOSTIC_TEST: [18F]-RO6958948 — PET imaging of Tau aggregates
• DIAGNOSTIC_TEST: Elecsys (Roche) Abeta42, Ttau and Ptau — Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
• DIAGNOSTIC_TEST: Lumipulse (Fujirebio) Abeta42, Ttau and Ptau — Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid

Primary Outcomes

• Clinical diagnosis (Clinical diagnosis at last 1 day visit)
• Clinical Dementia Rating-Sum of Boxes (CDR-SB) (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.)

Secondary Outcomes

• Rate of cognitive decline as measured by MMSE. (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.)
• Rate of cognitive decline as measured in ADL-function. (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.)
• Rate of volume change of structural MRI measures and amyloid PET (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.)
• Rates of change on cerebrospinal fluid AD biomarkers (Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.)

Full Eligibility Criteria

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, CBS or ALS.
* 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.

Trial Locations

• Memory Clinic, Hospital of Ängelholm, Ängelholm, Sweden
• Memory Clinic, Skåne University Hospital, Malmo, Sweden

Frequently Asked Questions

Related Conditions

• Dementia
• Alzheimer Disease
• Parkinson Disease
• Lewy Body Disease
• Parkinson-Dementia Syndrome
• Frontotemporal Degeneration
• Semantic Dementia
• Progressive Nonfluent Aphasia
• Progressive Supranuclear Palsy
• Corticobasal Degeneration

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