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    Summary
    EudraCT Number:2014-000422-38
    Sponsor's Protocol Code Number:PET_imaging_of_Tau
    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:2014-08-05
    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 number2014-000422-38
    A.3Full title of the trial
    An open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tau
    A.4.1Sponsor's protocol code numberPET_imaging_of_Tau
    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, Region Skåne
    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 supportAvid Radiopharmaceuticals, Inc./Eli Lilly
    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, Region Skåne
    B.5.2Functional name of contact pointMemory Clinic
    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-AV-1451
    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 Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions.
    E.1.1.1Medical condition in easily understood language
    Diseases affecting the brain, such as dementia disorders or movements disorders.
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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 17.0
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) Main objective: To examine the efficacy of raised [18F]-AV-1451 brain uptake for detecting cerebral accumulation of Tau in patients with Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and frontotemporal dementia (FTD) and to study whether the regional distribution of raised [18F]-AV-1451 brain uptake differs between these disorders.
    1) (Huvudfrågeställning) Kan PET undersökning med liganden [18F]-AV-1451 detektera upplagring av Tau i hjärnan vid AS, FTD, PSP, och/eller KBD och skiljer sig den regionala upplagringen mellan dessa sjukdomar?
    E.2.2Secondary objectives of the trial
    2) To study whether raised regional [18F]-AV-1451 brain uptake can distinguish AD and/or FTD from other dementia disorders that are not characterised by Tau accumulation, including vascular dementia (VaD), Dementia with Lewy bodies (DLB) and Parkinson’s disease with dementia (PDD).
    3) To study whether raised regional [18F]-AV-1451 brain uptake can distinguish PSP and/or CBD from other parkinsonian disorders that are not characterised by Tau accumulation, including Parkinson’s disease (PD) and multiple system atrophy (MSA).
    4) To determine whether cognitively healthy elderly individuals or patients with mild cognitive symptoms, who exhibit raised [18F]-AV-1451 brain uptake, will develop AD in the future.
    2) Kan [18F]-AV-1451 PET skilja AS och/eller FTD från andra demenssjukdomar som INTE har upplagring av Tau så som vaskulär demens och Lewy body demens?
    3) Kan [18F]-AV-1451 PET skilja PSP och/eller KBD från andra sjukdomar med parkinsonism som INTE har upplagring av Tau så som PS och MSA?
    4) Kan [18F]-AV-1451 PET tillsammans med andra biomarkörer förutsäga vem som kommer utveckla AS (eller annan tauopati) hos friska äldre eller patienter med lindriga kognitiva svårigheter och hur vanligt är tau-förändringar hos friska äldre?
    5) Ändrar sig upplagringen av Tau (visualiserat med [18F]-AV-1451 PET) över en 1-2 års period?

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The healthy controls should fulfil the following criteria i) at least 60 years of age ii) no cognitive symptoms, iii) MMSE score 28-30, iv) do not fulfil the criteria of mild cognitive impairment or dementia; v) no significant neurological or psychiatric disorder.

    The patients with mild cognitive symptoms should fulfil the following criteria: i) at least 60 years of age ii) mild cognitive symptoms, iii) MMSE score 24-30, iv) do not fulfil the criteria of dementia.

    The patients clinically diagnosed with a “tauopathy” will be at least 50 years of age and they should fulfil the current clinical criteria of AD, FTD, PSP, CBD, PD, PDD, DLB, MSA or VaD.
    E.4Principal exclusion criteria
    The exclusion criteria of the present study are:
    - History of alcohol or substance abuse or dependence within the last five years.
    - Current major depressive disorder.
    - History of schizophrenia or other recurrent psychotic disorder.
    - Diseases that will make study participation difficult, such as metastatic cancer disease, severe renal or hepatic impairment or significant infectious disease.
    - Have received or participated in a trial with investigational medications in the past 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    Visual detection of [18F]-AV-1451 brain retention in patients compared to 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]-AV-1451 brain:cerebellar uptake ratios (SUVR) measured with a priori VOI analysis in patients compared to healthy volunteers.

    Associations of [18F]-AV-1451 brain uptake ratios (SUVR) measured by VOI analysis with other diagnostic methods, including CSF biomarkers, FDG PET and MRI findings.

    Change in [18F]-AV-1451 brain uptake ratios (SUVR) measured by VOI analysis over time in patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    After dosing, PET-scanning and data analysis.
    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 years5
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state590
    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 Decision2014-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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