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    Summary
    EudraCT Number:2014-001315-40
    Sponsor's Protocol Code Number:RF-2010-2319722
    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:2014-10-10
    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 number2014-001315-40
    A.3Full title of the trial
    Amyloid Imaging in the “Italian Network for autosomal dominant Alzheimer’s disease and frontotemporal lobar degeneration (ItalianDIAfN)”
    Amyloid-PET all’interno dello studio “Network italiano per le forme autosomiche dominanti di malattia di Alzheimer e di degenerazione lobare frontotemporale (ItalianDIAfN)”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN study
    Effettuazione della scansione PET con tracciante per l'amiloide (Florbetapir 18F-PET) in soggetti portatori di mutazione genetica patogenetica per la malattia di Alzheimer partecipanti al progetto di ricerca ItalianDIAfN
    A.3.2Name or abbreviated title of the trial where available
    Amyloid-PET in ItalianDIAfN
    Scansione PET con tracciante per l'amiloide nello studio ItalianDIAfN
    A.4.1Sponsor's protocol code numberRF-2010-2319722
    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 SponsorIRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
    B.1.3.4CountryItaly
    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 (drug supply)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMinistry of Health (research support)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
    B.5.2Functional name of contact pointLENITEM
    B.5.3 Address:
    B.5.3.1Street Addressvia Pilastroni 4
    B.5.3.2Town/ cityBrescia
    B.5.3.3Post code25125
    B.5.3.4CountryItaly
    B.5.4Telephone number00390303501335
    B.5.5Fax number00390303501592
    B.5.6E-mailgiovanni.frisoni@gmail.com
    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 Amyvid
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA – Houten, The Nederlands
    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 nameFlorbetapir (18F)
    D.3.2Product code Florbetapir (18F)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNflorbetapir (18F)
    D.3.9.1CAS number 956103-76-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB33779
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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
    Autosomal Dominant Alzheimer's Disease
    Malattia di Alzheimer di tipo autosomico dominante
    E.1.1.1Medical condition in easily understood language
    Familial Alzheimer's Disease, i.e. due to genetic mutation in the APP, PSEN1, or PSEN2 gene.
    Forme familiari di malattia di Alzheimer, cioè causate da una mutazione genetica in uno dei geni tra APP, PSEN1, PSEN2
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to demonstrate the feasibility of F18 amyloid imaging in the context of multidimensional clinical, imaging, and biomarker collection in subjects coming from families with autosomal dominant AD
    Testare la fattibilità di implementare un protocollo standardizzato per l’acquisizione dell’esame PET con Florbetapir in soggetti appartenenti a famiglie con malattia di Alzheimer di tipo autosomico dominante, all’interno di uno studio multi-centrico italiano volto a raccogliere marcatori clinici e strumentali (imaging e biologici) di malattia
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age≥18;
    • Member of a family with a known mutation for autosomal dominant AD and aware of his/her genetic status: either an affected mutation carrier with a diagnosis of AD or a consanguineous of an affected mutation carrier who is a pre-symptomatic mutation carrier;
    • Willing and able to provide written Informed Consent to the study;
    • Have an identified informant (minimum of one), not consanguineous, who can serve as a collateral source for the ItalianDIAfN study.
    - Età maggiore o uguale a 18 anni
    - Soggetti sintomatici portatori di una mutazione causativa della malattia di Alzheimer, a conoscenza del proprio stato genetico
    - Soggetti asintomatici portatori di una mutazione causativa della malattia di Alzheimer, a conoscenza del proprio stato genetico
    - Essere in grado di fornire il consenso informato
    - Abbia identificato un informatore (almeno 1) non consanguineo, che possa servire da fonte collaterale per lo studio
    E.4Principal exclusion criteria
    • Is a cognitively normal non mutation carrier, consanguineous of an affected subject carrying a mutation for Alzheimer's Disease;
    • Is not able / not willing to provide written Informed Consent;
    • Has a medical or psychiatric illness that would interfere in completing the assessment;
    • Suffers from claustrophobia;
    • Has ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ-secretase or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial;
    • Is receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
    • Is woman of childbearing potential 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-hCG on 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 florbetapir (18F). Men must avoid pregnancy with a female partner for 24 hours after administration of florbetapir (18F).
    - Soggetti asintomatici non portatori di mutazione causativa per la malattia di Alzheimer
    - Soggetti non in grado di fornire un consenso informato
    - Presenza di condizione medica o psichiatrica che interferirebbe con le valutazioni
    - Claustrofobia
    - Assunzione di un farmaco sperimentale o partecipazione a una sperimentazione con farmaci sperimentali negli ultimi 30 giorni
    - Partecipazione a uno studio sperimentale con una terapia anti-amiloide (ad es. immunoterapia anti-amiloide, inibitore della γ- o β-secretasi), a meno che si possa dimostrare che il soggetto ha ricevuto soltanto il placebo nel corso della sperimentazione
    - Donne potenzialmente fertili che non sono chirurgicamente sterili e che non garantiscono di non astenersi dall’attività sessuale per le 24 ore successive alla somministrazione del radiotracciante fluorinato. Le donne potenzialmente fertili non devono essere in stato di gravidanza (β- hCG urinaria negativa al momento dello screening e β-hCG urinaria negativa nel giorno della PET) o allattare al momento dello screening. Le donne in età fertile devono impegnarsi a non intraprendere una gravidanza nei 10 giorni precedenti alla scansione PET e durante le 24 ore successive alla stessa. Gli uomini che partecipano allo studio dovranno impegnarsi a non far intraprendere una gravidanza alla partner, garantendo l’astensione dai rapporti sessuali per le 24 ore successive alla somministrazione del radiotracciante fluorinato.
    E.5 End points
    E.5.1Primary end point(s)
    N/A
    N/A
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility study in rare condition (autosomal dominant AD)
    Studio di fattibilità in popolazione rara (Malattia di Alzheimer di tipo autosomico dominante)
    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) Yes
    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 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 concerned11
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-10-10. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    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)
    Participants (or the informant) will be contacted within one/two working days after Florbetapir PET scanning for adverse events reporting.
    Un ricercatore dello studio contatterà telefonicamente il partecipante (o l’informatore, se il caso) uno o due giorni lavorativi successivi l’esecuzione della PET con Florbetapir per verificare le buone condizioni dello stesso e raccogliere informazioni relative ad eventuali eventi avversi intervenuti nelle 24 ore successive l’esecuzione della scansione PET.
    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 Decision2014-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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