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    Summary
    EudraCT Number:2015-001184-39
    Sponsor's Protocol Code Number:FBPASL5-01
    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:2017-12-13
    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 number2015-001184-39
    A.3Full title of the trial
    Assessing Florbetaben PET Patterns in MCI Patients for an Improved Prediction of Conversion to AD
    Valutazione della distribuzione regionale delle placche di β-amiloide tramite PET cerebrale con Neuraceq per predire la conversione da MCI a AD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of regional distribution of amyloid for predicting conversion fron Mild Cognitive Impairment to Alzheimer Disease
    Studio sulla distribuzione regionale dell'amiloide per la predizione della conversione da Declino Cognitivo Lieve a Demenza di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    Regional distribution of beta-amyloid with cerebral PET with Neuraceq
    Distribuzione regionale beta-amiloide tramite PET cerebrale con Neuraceq
    A.4.1Sponsor's protocol code numberFBPASL5-01
    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 SponsorASL 5 SPEZZINO
    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 supportPIRAMAL IMAGING Gmbh
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASL 5 SPEZZINO
    B.5.2Functional name of contact pointMedicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressVia vittorio Veneto 197
    B.5.3.2Town/ cityLa Spezia
    B.5.3.3Post code19121
    B.5.3.4CountryItaly
    B.5.4Telephone number0187533237
    B.5.5Fax number0187533224
    B.5.6E-mailandrea.ciarmiello@asl5.liguria.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 nameNEURACEQ
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlorbetaben (18F)
    D.3.9.2Current sponsor code07005801
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Mild Cognitive Impairment
    Declino Cognitivo Lieve
    E.1.1.1Medical condition in easily understood language
    Cognitive Impairment
    Declino 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 20.0
    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
    Identification of regional patterns of Neuraceq cortical ritention
    Identificazione di pattern regionali di ritenzione corticale del Neuraceq
    E.2.2Secondary objectives of the trial
    Evaluation of the pattern of regional Neuraceq cortical retention as predictors of conversion to AD.
    Evaluation of regional pattern of Neuraceq retention and semi-quantitative data analysis as predictors of conversion to AD
    Valutazione dei pattern regionali di ritenzione corticale del Neuraceq come predittori di conversione ad AD.
    Valutazione dei pattern regionali di ritenzione del Neuraceq e dei dati di analisi semi-quantitativa come predittori di conversione ad AD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of MCI according to the criteria of Petersen
    History of cognitive decline and cognitive impairment at the neuropsychological
    evaluation
    > 60 years of age
    Absence of criteria for the diagnosis of vascular dementia
    score> 24 on the Mini-Mental State Examination
    No history of addiction to alcohol or drugs
    Absence of psychiatric illness
    Willingness to give informed consent
    Diagnosi di MCI secondo i criteria di Petersen
    Storia di declino cognitivo e deterioramento cognitivo alla valutazione neurospicologica
    >60 anni di età
    Assenza di criteri per la diagnosi di demenza vascolare
    Punteggio >24 al Mini-Mental State Examination
    Assenza di storia di dipendenza da alcool o da droghe
    Assenza di malattie psichiatriche
    Disponibilità a dare il consenso informato
    E.4Principal exclusion criteria
    Diagnosis of dementia according to the ICD-10 criteria
    • Score ≤ 23 at the Mini-Mental State Examination
    • Diagnosis of Vascular dementia
    • Presence of psychiatric illness
    • Presence of diseases or medications that may alter the function or brain structures
    • A history of bleeding in the brain
    • Previous ischemic stroke
    • Presence of brain tumor
    • Presence of hydrocephalus
    •Epatic and renal abnormalities
    • Diagnosi di Demenza secondo i criteri ICD-10
    •Punteggio ≤ 23 al Mini-Mental State Examination
    •Diagnosi di Demenza vascolare
    •Presenza di malattie psichiatriche
    •Presenza di malattie o assunzione di farmaci che possono alterare la funzione o la strutture cerebrali
    •Pregresse emorragie cerebrali
    •Pregresso ictus ischemico
    •Presenza di tumore cerebrale
    •Presenza di idrocefalia
    •Alterazioni epatiche e renali
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the frequency of specific patterns of Neuraceq retention in patients who convert to AD and in patients who do not convert to AD.
    Valutazione della frequenza di specifici pattern di ritenzione del Neuraceq nei pazienti che convertono ad AD e nei pazienti che non convertono ad AD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 yars
    2 anni
    E.5.2Secondary end point(s)
    Evaluation of specific patterns of Neuraceq retention and SUVR as predictors of conversion from MCI to AD, through statistical regression analysis.
    Valutazione di specifici pattern di ritenzione del Neuraceq e degli SUVR come predittori di conversione da MCI ad AD, tramite analisi statistica di regressione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 anni
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 EEA0
    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 months4
    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 months4
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Considering the nature of the study, there are no plans for the treatament or the assistance of the subjects at the end of the study
    Vista la natura dello studio, non sono previsti trattamenti nè assistenza per i soggetti al termine dello studio
    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 Decision2015-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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