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    Summary
    EudraCT Number:2017-000094-36
    Sponsor's Protocol Code Number:BioFINDER_2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2017-000094-36
    A.3Full title of the trial
    The BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders
    BioFINDER 2 studien - förbättrad diagnostik och ökad förståelse av sjukdomsmekanismerna bakom kognitiva sjukdomar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disorders
    A.4.1Sponsor's protocol code numberBioFINDER_2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSkåne University Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHoffman La Roche Ltd.
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportGeneral Electric Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital
    B.5.2Functional name of contact pointMinneskliniken
    B.5.3 Address:
    B.5.3.1Street AddressSimrisbanvägen 14
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code20502
    B.5.3.4CountrySweden
    B.5.4Telephone number4640335435
    B.5.5Fax number4640334604
    B.5.6E-mailOskar.Hansson@med.lu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name18F-RO6958948
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vizamyl (flutemetamol(F-18))
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVizamyl
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimer's disease, progressive supranuclear palsy,
    frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.
    E.1.1.1Medical condition in easily understood language
    Diseases affecting the brain such as dementia or cognitive impairment; i.e. diseases that typically cause memory problems that the patient
    and/or relatives have noticed.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10053643
    E.1.2Term Neurodegenerative disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10012267
    E.1.2Term Dementia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLGT
    E.1.2Classification code 10028037
    E.1.2Term Movement disorders (incl parkinsonism)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10048598
    E.1.2Term Cognitive disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10012285
    E.1.2Term Dementia due to Pick's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10066571
    E.1.2Term Progression of Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study the diagnostic accuracy of Tau PET (18F-RO6958948) and Vizamyl (18F-Flutemetamol) for identifying healthy elderly individuals and patients with subjective or objective mild cognitive symptoms who are at high risk of subsequent development of dementia due to Alzheimer's disease (AD) or other neurodegenerative disorders.
    E.2.2Secondary objectives of the trial
    Study whether Tau pathology (visualized with 18F-RO6958948) or amyloid pathology (visualized using Vizamyl) in non-demented subjects affects functional and structural neuronal connectivity (visualized with MRI; i.e. resting state functional MRI, Arterial Spin Labeling, Diffusion Tensor Imaging, Kurtosis etc).
    - Study whether CSF biomarkers (especially P-tau, total-tau and oligomeric tau, but also markers of neuroinflammation) are associated with 18F-RO6958948 retention visualized with PET.
    - Study whether Tau pathology can precede amyloid pathology (visualized using Vizamyl) in preclinical AD, or whether Tau-pathology is always a consequence of amyloid accumulation.
    - Establish cut offs for pathological PET-scans in a healthy population.

    
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy elderly subjects
    - No cognitive symptoms reported by study participant
    - Normal performance on cognitive tests
    - General cognition and functional performance preserved such that a
    diagnosis of MCI or dementia cannot be made by physician at the time of the baseline visit
    - Between 20 and 100 years of age
    - Fluent in Swedish
    - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.

    Mild cognitive impairment/dementia
    - Cognitive symptoms reported by patient and/or informant
    - Between 20 and 100 years of age
    - General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by physician at the time of the baseline visit (MCI)
    - General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)
    - Fluent in Swedish
    - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    - Major depression as described in DSM-IV.
    - History of schizophrenia or other recurrent psychotic disorder
    - History of alcohol or substance abuse or dependence within the past 5 years
    - Diseases that will make study participation difficult, such as terminal cancer or significant heart failure.
    - Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, subdural hematoma, multiple sclerosis, or persistent neurologic deficits or known structural brain abnormalities.
    E.5 End points
    E.5.1Primary end point(s)
    Detection of specific signal of 18F-RO6958948 or 18F-Flutemetamol in patients with neurodegenerative disease or healthy volunteers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After dosing and PET-scanning.
    E.5.2Secondary end point(s)
    -18F-RO6958948 or 18F-Flutemetamol PET brain:cerebellar uptake ratios measured with a priori VOI analysis in subjects with neurodegenerative disease compared to
    healthy volunteers.
    -Associations of 18F-RO6958948 or 18F-Flutemetamol brain uptake ratios measured by VOI analysis with other diagnostic methods, including CSF biomarkers, cognitive tests and MRI findings.
    -Regional differences in distribution of 18F-RO6958948 or 18F-Flutemetamol brain uptake between different neurodegenerative disease conditions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After dosing and PET-scanning.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 900
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A few participants will have an advanced dementia and will not be able to give an informed consent. In these cases the closest relative or informant will be consulted and sign a consultation form ("samtycke") in accordance with Swedish law.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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