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    Summary
    EudraCT Number:2014-005389-31
    Sponsor's Protocol Code Number:FBB-HUG-2014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005389-31
    A.3Full title of the trial
    Incremental diagnostic value of Florbetaben Imaging vs other core biomarkers for Alzheimer Disease in patients with Mild Cognitive Impairment.
    An Investigator-Initiated Sponsored Study.
    Valore diagnostico incrementale di Florbetaben Imaging vs altri biomarcatori chiave per la Malattia di Alzheimer in pazienti con Deterioramento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Incremental diagnostic value of Florbetaben Imaging vs other core biomarkers for Alzheimer Disease in patients with Mild Cognitive Impairment.
    An Investigator-Initiated Sponsored Study
    Valore diagnostico incrementale di Florbetaben Imaging vs altri biomarcatori chiave per la Malattia di Alzheimer in pazienti con Deterioramento Cognitivo Lieve (MCI). Studio Spontaneo
    A.3.2Name or abbreviated title of the trial where available
    FBB-HUG-2014
    FBB-HUG-2014
    A.4.1Sponsor's protocol code numberFBB-HUG-2014
    A.5.4Other Identifiers
    Name:FBB-HUG-2014Number:FBB-HUG-2014
    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 SponsorHôPITAUX UNIVERSITAIRES DE GENèVE
    B.1.3.4CountrySwitzerland
    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 supportAzienda Farmaceutica: Piramal Imaging S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôPITAUX UNIVERSITAIRES DE GENèVE
    B.5.2Functional name of contact pointDipartimento Scientifico
    B.5.3 Address:
    B.5.3.1Street AddressRUE GABRIELLE-PERRET-GENTIL 4
    B.5.3.2Town/ cityGinevra
    B.5.3.3Post code1205
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0303501360
    B.5.5Fax number0303501592
    B.5.6E-mailmparapini@fatebenefratelli.it
    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 Yes
    D.2.1.1.1Trade name NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
    D.2.1.1.2Name of the Marketing Authorisation holderPIRAMAL IMAGING GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFlorbetaben
    D.3.2Product code BAY 94-9172
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Mild Cognitive Impairment
    Deterioramento Cognitivo Lieve
    E.1.1.1Medical condition in easily understood language
    Mild Cognitive Impairment
    Lievi disturbi di memoria
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10050727
    E.1.2Term RI scan
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to evaluate the incremental diagnostic value for MCI due to Alzheimer Disease (AD) of Florbetaben (FBB) Imaging versus CSF markers (Ab42, τ and ph-τ) in patients with MCI.
    L'obiettivo dello studio è valutare il valore diagnostico incrementale, per diagnosi di MCI dovuta a Malattia di Alzheimer (AD), del Florbetaben rispetto ai biomarcatori CSF (Ab42, τ and ph-τ) in pazienti con MCI
    E.2.2Secondary objectives of the trial
    //
    //
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written Inform Consent to participating;
    2. Subjects must be included in an ADNI compatible study including neuropsychological assessment, Magnetic Resonance (MR) at 1.5T or 3T, CSF collection and Abeta42 and tau assay. Neuropsychological assessment should include: Mini Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog), Rey Auditory Verbal Learning Test (AVLT), Logical Memory Test (immediate and delayed recall), Controlled Oral Word Association Test (COWAT), Category fluency, Boston Naming Test (BNT), Trail Making Test (TMT), Digit Symbol Substitution Test, Clock Drawing Test, Digit Span Forward and Digit Span Backward.
    3. Age between 55 and 90 years;
    4. Diagnosis of MCI (pure amnestic or multidomain);
    5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the screening visit;
    6. Mini Mental State Examination score between 24 and 30 (inclusive);
    7. Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R;
    8. Clinical Dementia Rating – Sum of Boxes (CDR-SB) = 0.5. Memory Box score must be at least 0.5;
    9. Geriatric Depression Scale (GDS) less than 6;
    10. Modified Hachinski Ischemic Scale (MHIS) < to 4;
    11. Memory complaint by patient or study partner that is verified by a study partner. (Memory complains expressed by the subjects or their informant that the examiner considers to be relevant and exceed those expected for a subject of their age. The subject may or may not have symptoms of deficiency in other cognitive areas);
    12. Stability of Permitted Medications for 4 weeks (see following pages for examples of permitted and excluded medications);
    13. At least 5 years education;
    14. Must speak (language) fluently;
    15. Have a study partner with 10+ hr/wk contact, accompanies to visits;
    16. Willing and able to comply with the requirements of the study, as judge by the investigator
    1. Consenso informato scritto a partecipare allo studio;
    2. I soggetti devono far parte di uno studio compatibile con gli standard ADNI comprendente la valutazione neuropsicologica, Risonanza Magnetica (RM) a 1.5 T o 3 T, campioni di CSF e analisi di Abeta42 e Tau. La valutazione neuropsicologica dovrebbe includere: Mini Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog), Rey Auditory Verbal Learning Test (AVLT), Logical Memory Test (richiamo immediato e differito), Controlled Oral Word Association Test (COWAT), Category fluency, Boston Naming Test (BNT), Trail Making Test (TMT), Digit Symbol Substitution Test, Clock Drawing Test, Digit Span Forward e Digit Span Backward;
    3. Età compresa tra 55 e 90 anni;
    4. Diagnosi di MCI (amnesico o a domini multipli);
    5. Funzionamento cognitivo generale e capacità funzionali sufficientemente preservate tali per cui al soggetto non possa essere diagnosticata una Malattia di Alzheimer al momento della visita di screening dal medico del centro;
    6. Punteggio al MMSE tra 24 e 30 (inclusi);
    7. Un funzionamento mnestico anormale rilevato dal punteggio di 1 deviazione standard sotto la media corretta per età ottenuto al Logical Memory II Subscale (richiamo immediato e differito) dalla Wechsler Memory Scale-R;
    8. Clinical Dementia Rating -Sum of Boxes (CDR-SB) = 0.5. Il punteggio nel dominio della memoria di almeno 0.5;
    9. Punteggio alla Geriatric Depression Scale (GDS) minore di 6;
    10. Punteggio alla Modified Hachinski Ischemic Scale (MHIS) minore di 4;
    11. Il disturbo di memoria deve essere confermato dal paziente o dal caregiver (ovvero i disturbi di memoria espressi dal paziente o dal caregiver che l'esaminatore ritiene rilevanti ed eccessivi rispetto a quanto ci si aspetterebbe da soggetti di pari età. Il paziente può o meno presentare sintomi di problematicità in altre aree cognitive);
    12. I farmaci permessi devono essere assunti in dosi stabili da 4 settimane (vedi paragrafo nel protocollo sui medicinali permessi);
    13. Almeno 5 anni di scolarità;
    14. Deve parlare fluentemente;
    15. Deve avere un partner di studio con cui ha contatti di 10 o più ore/settimana e che lo accompagni alle visite;
    16. Disponibile e in grado di aderire alle richieste dello studio, secondo giudizio dello sperimentatore
    E.4Principal exclusion criteria
    1. History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment;
    2. Visual and auditory acuity inadequate for neuropsychological testing;
    3. Enrollment in other trials or studies not compatible with FBB Imaging study;
    4. Use of forbidden medication (see paragraph in the protocol);
    5. Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture;
    6. Women of childbearing potential who are not surgically sterile and not refraining from sexual activity. Women of childbearing potential must not be pregnant (negative urine β-hCG at the time of screening and negative urine β-hCGon the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant in the 10 days prior to the PET scan and for 24 hours after administration of FBB Imaging. Men must avoid pregnancy with a female partner for 24 hours after administration of FBB Imaging;
    7. Participation in any other PET ligand study within 4 weeks of screening
    1. Storia di una significativa malattia neurologica o psichiatrica o presenza di altri disturbi che impediscano la sua ammissibilità;
    2. Acuità visiva e uditiva inadeguata per le valutazioni neuropsicologiche;
    3. Soggetti già arruolati in altri studi non compatibili con questo studio su FBB Imaging;
    4. Uso di medicinali proibiti (vedere paragrafo nel protocollo);
    5. Impianti ferromagnetici e dispositivi (inclusi gli impianti o dispositivi retti da suture, da granulazione o crescita interna di tessuto, dispositivi di fissaggio, o con altri mezzi), non ammissibili per la scansione MRI. Malformazione cerebrale o altre condizioni che possono complicare la puntura lombare;
    6. Donne potenzialmente fertili che non siano chirurgicamente sterili e non evitanti l'attività sessuale. Le donne potenzialmente fertili non devono essere in gravidanza (valore negativo β-hCG all'esame delle urine al momento dello screening e valore negativo β-hCGon nel giorno dell'imaging) o in fase di allattamento al momento dello screening. Le donne devono evitare di rimanere incinte nei 10 giorni precedenti lo screening e nelle 24 ore dopo la somministrazione dell'FBB. Gli uomini devono evitare gravidanza con la partner nelle 24 ore seguenti la somministrazione di FBB;
    7. Partecipazione in altri studi con ligandi PET entro 4 settimane dallo screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcomes will be the differences of the change of physician’s diagnostic confidence (incremental confidence) between Rounds 1-2 and 2-3. Assuming that FBB imaging will be superior to CSF biomarker results, incremental confidence between Rounds 1-2 will represent the advantage of FBB imaging over CSF biomarker results between Clinical Raters, and incremental confidence between Rounds 2-3 will represent the advantage of FBB imaging over CSF biomarker results within Clinical Raters. Physician’s confidence will be validated versus adverse cognitive outcomes (development of dementia and cognitive deterioration) after 1 and 2 years
    Gli Outcome primari verteranno sulle differenze nella variazione di confidenza diagnostica (confidenza incrementale) dei medici tra le fasi 1-2 e 2-3. Assumendo che i risultati al FBB Imaging siano superiori rispetto ai risultati dei biomarcatori nel CSF, la confidenza incrementale tra le fasi 1 e 2 rappresenterà la superiorità dei risultati del FBB Imaging sui biomarcatori nel CSF tra i Clinical Rater, e la confidenza incrementale tra le fasi 2 e 3 rappresenterà la superiorità dei risultati del FBB Imaging sui risultati dei biomarcatori nel CSF entro i Clinical Raters. La confidenza dei medici verrà confermata rispetto alla comparsa di esiti cognitivi avversi (sviluppo di demenza e deterioramento cognitivo) dopo 1 e 2 anni.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of clinical trial
    Fine dello studio clinico
    E.5.2Secondary end point(s)
    Secondary outcomes will be (i) the predictivity of cognitive outcomes by FBB imaging. The predictivity of hippocampal volumetry, CSF biomarkers, and FBB imaging towards cognitive outcomes at 1 and 2 years will be studied. The predictivity of FBB imaging will be contrasted to predictivity of the other biomarkers; and (ii) the agreement of the local reading by nuclear medics among themselves and with the centralized reading, and (iii) the agreement between local and centralized assays of CSF Ab42, whenever available
    Gli Outcome secondari riguarderanno (i) la capacità predittiva di outcomes cognitivi del FBB imaging. Verrà studiata la predittività degli esiti cognitivi a 1 anno e a 2 anni della volumetria ippocampale, dei biomarcatori nel CSF e del FBB Imaging. La capacità predittiva del FBB Imaging sarà messa a confronto con quella degli altri biomarcatori; i risultati secondari riguarderanno inoltre (ii) l'accordo sulle letture locali dei medici nucleari e con la lettura centralizzata, e (iii) l'accordo tra le analisi locali e centrali del CSF Ab42, quando disponibili
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of clinical tial
    Fine dello studio clinico
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Neither treatments nor care after ending the clinical trial is foreseen
    Non è previsto nessun programma per il trattamento al termine della sperimentazione clinica
    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 Decision2015-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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