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    Summary
    EudraCT Number:2019-002473-65
    Sponsor's Protocol Code Number:PET-PiB
    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:2020-10-22
    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 number2019-002473-65
    A.3Full title of the trial
    PET-CT study of cerebral regional amyloid burden in Patients with suspected Alzheimer’s disease
    Studio PET-TC del carico amiloideo regionale cerebrale in Pazienti con sospetta malattia di Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PET-CT study of cerebral regional amyloid burden in Patients with suspected Alzheimer’s disease
    Studio PET-TC del carico amiloideo regionale cerebrale in Pazienti con sospetta malattia di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    PET-PiB
    PET-PiB
    A.4.1Sponsor's protocol code numberPET-PiB
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO GEMELLI
    B.5.2Functional name of contact pointDirezione Scientifica Fondazione Po
    B.5.3 Address:
    B.5.3.1Street AddressLargo Agostino Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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 name2-(4'-[11C]metilamminofenil)-6-idrossibenzotiazolo
    D.3.2Product code [11CPiB]
    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.3.8INN - Proposed INN2-(4'-[11C]metilamminofenil)-6-idrossibenzotiazolo
    D.3.9.1CAS number 566169-93-5
    D.3.9.2Current sponsor code[11C]PiB
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number120 to 300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Patients with amnestic or non-amnestic MCI or early dementia
    Pazienti con MCI amnesico o non amnesico o demenza in fase iniziale
    E.1.1.1Medical condition in easily understood language
    Patients with amnestic or non-amnestic MCI or early dementia
    Pazienti con MCI amnesico o non amnesico o demenza in fase iniziale
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10053643
    E.1.2Term Neurodegenerative disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of cerebral regional amyloid burden, by absolute quantitative analysis of 11C-PiB PET images
    Valutazione del carico di amiloide regionale cerebrale, mediante una analisi quantitativa assoluta delle immagini PET con 11C-PiB
    E.2.2Secondary objectives of the trial
    Correlation between the cerebral regional amyloid burden and the neuropsychological evaluation
    Correlazione tra il carico di amiloide regionale cerebrale e la valutazione neuropsicologica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 65-75 years
    - Patients either with amnesic or non-amnesic MCI or dementia (MMSE score > 20), evaluated for the first time due to a recent (within 3 years) onset cognitive impairment, according to the Italian and European recommendations
    - Patients able to express informed consent
    - Educational level > 2 years
    - Availability of a reliable caregiver
    - Età: 65-75 anni
    - Pazienti con MCI amnesico o non amnesico o con demenza (punteggio MMSE> 20), valutati per la prima volta a causa di un recente decadimento cognitivo (entro 3 anni), secondo le raccomandazioni italiane ed europee
    - Pazienti in grado di esprimere il consenso informato
    - Livello di istruzione > 2 anni
    - Disponibilità di un caregiver affidabile
    E.4Principal exclusion criteria
    - Age < 65 years or > 75 years
    - Patients with other neurological diseases
    - Patients with uncontrolled systemic pathologies
    - Severe sensorial reduction in sight or hearing hampering neuropsychological tests
    - Illiteracy
    - Età < 65 anni o > 75 anni
    - Pazienti portatori di altre patologie neurologiche
    - Pazienti con patologie sistemiche incontrollate
    - Grave riduzione sensoriale della vista o dell'udito che ostacola i test neuropsicologici
    - Analfabetismo
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative differences in amyloid burden among different brain areas
    Differenze quantitative del carico di amiloide fra le diverse regioni cerebrali
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 48 hours
    Entro 48 ore
    E.5.2Secondary end point(s)
    Neuropsychological evaluation
    Valutazione neuropsicologica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 48 hours
    Entro 48 ore
    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) 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 No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 years2
    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 years2
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    Any plans for treatment or care after a subject has ended his/her participation in the trial, since study do not interfer with the subsequent diagnostic and therapeutic plan
    Non sono previsti programmi per il trattamento o l'assistenza per i soggetti al termine della loro partecipazione allo studio, perchè lo studio non interferisce con il successivo iter diagnostico e terapeutico
    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 Decision2021-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-12-16
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