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    Summary
    EudraCT Number:2016-003878-41
    Sponsor's Protocol Code Number:GE-180-01
    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:2021-06-08
    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 number2016-003878-41
    A.3Full title of the trial
    SINGLE ARM, OPEN-LABEL, UNCONTROLLED PHASE II PILOT STUDY ON BRAIN PET WITH THE TRACER [18F]GE-180 (18FGEH120714) IN PATIENTS AFFECTED BY COGNITIVE DECLINE
    STUDIO PILOTA DI FASE II IN APERTO A BRACCIO SINGOLO NON CONTROLLATO DI PET CEREBRALE CON TRACCIANTE [18F]GE-180 (18FGEH120714) IN PAZIENTI AFFETTI DA DECADIMENTO COGNITIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study by mean of brain positron emission tomography (PET) of a tracer specific for inflammation [[18F]GE-180, or 18FGEH120714] in patients affected by cognitive impairment
    STUDIO DI PET CEREBRALE CON TRACCIANTE [18F]GE-180 (18FGEH120714) IN PAZIENTI AFFETTI DA DECADIMENTO COGNITIVO
    A.3.2Name or abbreviated title of the trial where available
    GE-180-01
    GE-180-01
    A.4.1Sponsor's protocol code numberGE-180-01
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    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 supportMINISTERO DELLA SALUTE
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationU.O. NEUROLOGIA - NEUROFISIOPATOLOGIA
    B.5.2Functional name of contact pointU.O. NEUROLOGIA - NEUROFISIOPATOLOG
    B.5.3 Address:
    B.5.3.1Street AddressVIA ROMA 67
    B.5.3.2Town/ cityPISA
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number050992443
    B.5.5Fax number050554808
    B.5.6E-mailf.giorgi@ao-pisa.toscana.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.3.4Pharmaceutical form Solution for infusion
    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 INN[18F]GEH120714
    D.3.9.2Current sponsor code[18F]GEH120714
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 affected by degenerative
    Decadimento cognitivo
    E.1.1.1Medical condition in easily understood language
    Patients affected by: a) dementia, i.e. a neurological condition associated to a decline of mental activity involving some cognitive aspects, such as memory, attention, language etc., and severe enoug
    Decadimento cognitivo
    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 LLT
    E.1.2Classification code 10009843
    E.1.2Term Cognitive deterioration
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.
    ¿ Valutare la presenza di differenze di distribuzione del tracciante [18F]GE-180, marker di attivazione microgliale, nel cervello di pazienti affetti da demenza legata a MA, rispetto a pazienti affetti da MCIa che non convertono in demenza legata a MA al follow up, ed a pazienti con MCIa che convertono in demenza legata a MA al follow up.
    E.2.2Secondary objectives of the trial
    ¿ To correlate the brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients
    ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementy and Lewy Body Dementia
    ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients
    ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters
    ¿ Correlare la distribuzione di tracciante [18F]GE-180 con il LC-CR nelle RMN precedentemente eseguite dai pazienti.
    ¿ Valutare la presenza di differenze di distribuzione del tracciante [18F]GE-180, marker di attivazione microgliale, nel cervello di pazienti affetti da demenza legata a MA rispetto a pazienti affetti da FTD, PDD o LBD.
    ¿ Valutare differenze nella distribuzione cerebrale del tracciante [18F]GE-180 tra i diversi pazienti all¿interno dello stesso gruppo (gruppo MA, MCIa converters, MCIa non-converters) che correli con caratteristiche cliniche e di gravit¿ dei singoli pazienti e durata dei disturbi.
    ¿ Valutare la differenza in termini di distribuzione del tracciante [18F]GE-180 tra i due gruppi MCIa converters versus MCIa non converters al follow-up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of both sexes, aged between 60 and 80 years; patients must be able to understand the protocol and to express a valid signed informed consent. Patients must have a relative or friend spending with them at least 10 hours/week (caregiver). Female patients must have been in menopause for at least twelve months before being included in the study. Patients must have a diagnosis of dementia due to AD probable according to National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) criteria and a CDR: 0,5-1 and raw MMSE score> 16; or a diagnosis of MCIa according to National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) criteria; or a diagnosis of fronto-temporal dementia probable (according to criteria by Neary et al., 1998, and Rascowsky et al., 2011), or a diagnosis of Parkinson's Disease Dementia (according to criteria by Emre et al.2007) or a diagnosis of Lewy Body Dementia probable (according to criteria by McKeith et al. 2005). Patients will have been submitted to an MRI in the previous 6 months, during their diagnostic work up.
    Tutti i seguenti criteri dovranno essere soddisfatti contemporaneamente per procedere all’arruolamento:
    • Pazienti di entrambi i sessi, etnia Caucasica e di età compresa tra 60 e 80 anni;
    • I pazienti devono essere in grado di comprendere e aderire a quanto richiesto dal protocollo dello studio e devono fornire personalmente il consenso informato scritto. Qualora il paziente abbia precedentemente nominato un tutore legale, questi deve fornire il consenso scritto;
    • I pazienti devono avere un caregiver, definito come persona, familiare o non, che trascorra con essi almeno 10 ore settimanali e possa riferire in merito alle attività quotidiane degli stessi. Anche il caregiver dovrà firmare il consenso informato;
    • I pazienti di sesso femminile devono essere già in menopausa al momento dell’inizio dello studio, con ultima mestruazione documentata ameno 12 mesi prima dell’inclusione nello studio;
    • I pazienti dovranno avere una diagnosi di:
    -MA probabile secondo i criteri National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) (McKhann et al., 2011) e con CDR: 0,5-1; punteggio grezzo di MMSE superiore a 16;
    oppure:
    - MCIa secondo i criteri National Institute on Aging–Alzheimer's Association – 2011 (NIA-AA) (Albert et al., 2011);
    oppure:
    - FTD probabile secondo i criteri diagnostici di Neary et al. (1998) e Rascowsky et al.(2011);
    oppure:
    - PDD probabile secondo i criteri diagnostici di Emre et al. (2007);
    oppure:
    - LBD probabile secondo i criteri diagnostici di McKeith et al. (2005);

    • i pazienti dovranno aver eseguito un’indagine, di RMN encefalo nei 6 mesi precedenti, nel corso loro iter diagnostico per disturbi cognitivi.
    E.4Principal exclusion criteria
    Patients with a psychiatric illness diagnosis (Axis 1 or 2 of DSM IV, schizophrenia, bipolar disorder, uncontrolled major depression) and neurological disorders potentially causing/concurring to the cognitive complaints in researcher’s judgment. Patients with cognitive disorders secondary to concomitant medical conditions . Patients participating to clinical trials involving AD disease-modifying treatments, registered on ClicalTrials.gov. Patients treated with NSAIDs or cortisone-based drugs orally or e.v. in the 28 days preceding PET exam. Alcohol or Substance abusers. Patients not able to express valid consent. Patients with moderate/severe cerebrovascular disease (according to modified Fazekas score). Patients with physical/medical conditions contraindicating venous access positioning. Patients with severe infective comorbidities such as sepsis, pneumonia, within 30 days of enrollment, or previous meningoencephalitis. Patients with severe medical or cardiologic comorbidities.
    I pazienti saranno esclusi dallo studio per ognuna delle seguenti motivazioni:
    • Pazienti con disturbi psichiatrici (Asse 1 o 2 del DSM IV, schizofrenia, disturbo bipolare, depressione maggiore mal controllata) e patologie neurologiche potenzialmente responsabili/corresponsabili di disturbi cognitivi a giudizio degli sperimentatori;
    • Pazienti con disturbi cognitivi secondari a gravi patologie internistiche, a giudizio degli sperimentatori;
    • Pazienti già partecipanti a trials clinici che comportino l’utilizzo di farmaci potenzialmente “disease modifying” su comparsa/decorso della MA, come da registrazione su ClicalTrials.gov;
    • Terapia cronica (almeno 1 volta/settimana) con farmaci cortisonici sistemici e/o farmaci antinfiammatori non steroidei (FANS) – vedi Appendice 1, per via orale o endovenosa.
    • Pazienti alcolisti o utilizzatori di altre sostanze d’abuso;
    • Pazienti non in grado di fornire un valido consenso informato scritto;
    • Pazienti con presenza di una compromissione cerebrovascolare moderata-grave secondo la scala di Fazekas modificata (Wahlund et al., 2001)
    • Patologie e/o condizioni fisiche che controindicano il posizionamento di un accesso venoso
    • Pazienti con gravi comorbidità infettivologiche come storia di setticemia e polmonite (entro 30 giorni prima dell’arruolamento) e di meningoencefaliti o meningiti di qualsiasi eziologia;
    • Disfunzione epatica definita da valori di bilirubina totale >1,5 mg/dl, SGOT e SGPT > 2.5 volte il valore normale;
    • GFR stimato < 60 mL/min/1.73 m2
    • Precedenti neoplasie sottoposte a trattamento chemio o radioterapico negli ultimi sei mesi prima dell’arruolamento;
    • Pazienti con gravi comorbidità internistiche e cardiologiche, rappresentate da diagnosi pregressa di cardiopatia ischemica su base clinica o strumentale, pregresso infarto del miocardio; valvulopatie (steno e/o insufficienza aortica o mitralica) di grado superiore al lieve; scompenso cardiaco congestizio (New York Heart Association class > 2),
    • Riscontro all’elettrocardiogramma di ritmo non sinusale e/o presenza di blocco di branca sinistra e/o QTc > 450 ms;
    • Ipersensibilità al principio attivo e/o agli eccipienti e/o altri radiofarmaci e radiotraccianti.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia, as compared with patients affected by MCIa converting in dementia at follow up, and patients with MCIa non converting to dementia at follow-up.
    • Vi sono differenze di distribuzione del tracciante di attivazione microgliale [18F]GE-180, nel cervello di pazienti affetti da demenza legata a MA rispetto a pazienti affetti da MCIa converters in demenza al follow up, a pazienti con MCIa non converters in demenza al follow up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 16th months from study start a first interim analysis will be performed to assess data in patients recruited up to this time point and reevaluate whether primary end-point will be achieved with a number of patients lower than expected. A final analysis will be performed at 36 months after enrollment of first patient
    16 e 36 mesi
    E.5.2Secondary end point(s)
    ¿ Correlation of brain distribution of the neuroinflammation marker [18F]GE-180 in single patients with a brain RMN marker of the noradrenergic brain nucleus Locus Coeruleus assessed on MRI previously performed in the same patients; ¿ Analysis of differences in the brain distribution of the neuroinflammation marker [18F]GE-180 in the brain of patients affected by AD dementia as compared with patients affected by fronto-temporal dementia, Parkinson's Disease Dementia and Lewy Body Dementia ; ¿ Analysis differences in the brain distribution of the neuroinflammation marker [18F]GE-180 within the groups AD dementia, MCIa converters and MCIa non converters, which are related to the severity clinical features and disease duration of patients; ¿ To evaluate whether there are differences in the brain distribution of the neuroinflammation marker [18F]GE-180 between the groups of MCIa converters and MCIa non converters
    ¿ Vi ¿ una correlazione tra la distribuzione di tracciante [18F]GE-180 alla PET cerebrale e la compromissione del LC-CR nelle RMN precedentemente eseguite dai pazienti.; ¿ Vi sono differenze di distribuzione del tracciante [18F]GE-180, nel cervello di pazienti affetti da demenza legata a MA rispetto a pazienti affetti da FTD, PDD o LBD.; ¿ Vi sono differenze nella distribuzione cerebrale del tracciante [18F]GE-180 tra i diversi pazienti all¿interno del gruppo con demenza legata a MA ed MCIa converters correlate con le caratteristiche cliniche e durata dei disturbi.; ¿ Valutare la differenza in termini di distribuzione del tracciante [18F]GE-180 tra i due gruppi MCIa converters versus MCIa non converters al follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient; A final analysis will be performed at 36 months after enrollment of first patient
    36 mesi; 36 mesi; 36 mesi; 36 mesi
    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) 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    Patients of the study will be recruited from patients admitted as outpatients at the Neurology Unit of Azienda Ospedaliero-Universitaria Pisana. After the end of the study they will continue to be submitted to follow up visits at the neurology Unit and to any standard treatment in relation to their clinical diagnosis, unless the patients themselves decide not to be followed up at this Center anymore
    I pazienti saranno seguiti come di routine
    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 Decision2016-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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