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    Summary
    EudraCT Number:2012-004328-40
    Sponsor's Protocol Code Number:INMINDFP7-HEALTH-2011-two-stage
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-23
    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 number2012-004328-40
    A.3Full title of the trial
    IMAGING OF NEUROINFLAMMATION IN NEURODEGENERATIVE DISEASES
    INMIND STUDIO DELLA NEUROINFIAMMAZIONE NELLE PATOLOGIE NEURODEGENERATIVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLA
    studio della infiammazione della struttura dei nervi nelle malattie quali Alzheimer, declino cognitivo lieve, demenza e sclerosi laterale amiotrofica
    A.4.1Sponsor's protocol code numberINMINDFP7-HEALTH-2011-two-stage
    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 SponsorOSPEDALE S. RAFFAELE DI MILANO
    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 supportProgramma Europeo FP7-HEALTH-2011-two-stage
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointMedicina Nucleare
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina,60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02.26432224
    B.5.5Fax number02.26435202
    B.5.6E-mailperani.daniela@hsr.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 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 nameNA
    D.3.2Product code (R)-[N-metil-11C1-PK11195(PK)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code(R)-[N-metil-11C]-PK11195
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number185
    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, Alzheimer disease,frontotemporal dementia, SLA
    declino cognitivo lieve, malattia di Alzheimer, demenza frontotemporale, sclerosi laterale amiotrofica
    E.1.1.1Medical condition in easily understood language
    cognitive and motor impairment
    disturbi cognitivi e motori
    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 14.1
    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
    to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases
    utilizzare il radiotracciante [11C]PK-PET imaging come biomarcatore precoce applicabile in campo clinico, con la metodica PET, nelle patologie neurodegenerative.
    E.2.2Secondary objectives of the trial
    (i) to identify novel mechanisms of regulation and function of microglia under various conditions (inflammatory stimuli; neurodegenerative and -regenerative model systems); (ii) to identify and implement new targets for activated microglia, which may serve for diagnostic (imaging) and therapeutic purposes; (iii) to design new molecular probes (tracers) for these novel targets and to implement and validate them in in vivo model systems and patients; (iv) to image and quantify modulated microglia activity in patients undergoing immune therapy for cognitive impairment and relate findings to clinical outcome.
    (i) identificare nuovi meccanismi di regolazione e la funzione della microglia in varie condizioni (stimoli infiammatori, sistemi modello di tipo neurodegenerativo e rigenerativo); (ii) individuare ed implementare nuovi obiettivi per la microglia attivata, che possano essere utili per la diagnostica (imaging) e a fini terapeutici; (iii) progettare per questi obiettivi nuovi nuovi traccianti da validare in sistemi modello in vivo e nei pazienti; (iv) quantificare l'attività modulata della microglia in pazienti sottoposti a terapia immunitaria per peggioramento cognitivo e correlati di esito clinico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients with neurodegenerative diseases (mild cognitive impairment, Alzheimer's disease, frontotemporal dementia, amyotrophic lateral sclerosis SLA) on a sporadic or genetic base; male and female patients aged over 18 years.
    pazienti affetti da malattie neurodegenerative (declino cognitivo lieve, malattia di Alzheimer, demenza frontotemporale, sclerosi laterale amiotrofica) su base sporadica o genetica; pazienti maschi e femmine di eta' superiore ai 18 anni
    E.4Principal exclusion criteria
    focal brain , physical, psychiatric or metabolic disorders which might otherwise explain the cognitive and / or motor impairment.
    patologie cerebrali focali, fisiche, psichiatriche o metaboliche che possano altrimenti spiegare i disturbi cognitivi e/o motori.
    E.5 End points
    E.5.1Primary end point(s)
    to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases
    utilizzare il radiotracciante [11C]PK-PET imaging come biomarcatore precoce applicabile in campo clinico, con la metodica PET, nelle patologie neurodegenerative.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the study
    al termine dello studio
    E.5.2Secondary end point(s)
    i) identificare nuovi meccanismi di regolazione e la funzione della microglia in varie condizioni (stimoli infiammatori, sistemi modello di tipo neurodegenerativo e rigenerativo); (ii) individuare ed implementare nuovi obiettivi per la microglia attivata, che possano essere utili per la diagnostica (imaging) e a fini terapeutici; (iii) progettare per questi obiettivi nuovi nuovi traccianti da validare in sistemi modello in vivo e nei pazienti; (iv) quantificare l'attività modulata della microglia in pazienti sottoposti a terapia immunitaria per peggioramento cognitivo e correlati di esito clinico
    (i) identificare nuovi meccanismi di regolazione e la funzione della microglia in varie condizioni (stimoli infiammatori, sistemi modello di tipo neurodegenerativo e rigenerativo); (ii) individuare ed implementare nuovi obiettivi per la microglia attivata, che possano essere utili per la diagnostica (imaging) e a fini terapeutici; (iii) progettare per questi obiettivi nuovi nuovi traccianti da validare in sistemi modello in vivo e nei pazienti; (iv) quantificare l'attività modulata della microglia in pazienti sottoposti a terapia immunitaria per peggioramento cognitivo e correlati di esito clinico
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study
    al termine dello studio
    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) 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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 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.1.1Number of subjects for this age range: 0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    no therapeutic program is planned at the end of the study
    non e' previsto alcun 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 Decision2013-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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