Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-001599-12
    Sponsor's Protocol Code Number:18F-AV-45-C01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001599-12
    A.3Full title of the trial
    The clinical value of amyloid imaging with [18F]-AV45 in a population of memory clinic patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determine the value of the compound [18F]-AV45, which is usable for visualization of the build-up of the amyloid protein in brains of memory clinic patients, in making a diagnosis in patients of the memory outpatient clinic.
    A.3.2Name or abbreviated title of the trial where available
    Clinical value AV-45
    A.4.1Sponsor's protocol code number18F-AV-45-C01
    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 SponsorVU University Medical Center (VUmc)
    B.1.3.4CountryNetherlands
    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, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center (VUmc)
    B.5.2Functional name of contact pointAlzheimer center
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1118
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003100204440816
    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 Florbetapir F-18
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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) solution for injection
    D.3.2Product code 18F-AV-45
    D.3.4Pharmaceutical form Solution for injection
    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 INNflorbetapir (18F)
    D.3.9.1CAS number 956103-76-7
    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
    The total number of inclusion in this study is 170 subjects; 140 patients (including Alzheimer’s disease (AD) patients, patients with mild cognitive impairment (MCI), patients with subjective memory complaints (SMC), patients with other neurodegenerative diseases and 30 cognitively normal volunteers.
    In totaal worden 170 deelnemers geincludeerd, waarvan 140 patienten (inclusief Alzheimer (AD) patienten, patienten met milde cognitieve stoornissen (MCI), patienten met subjectieve klachten (SMC) en patienten met andere neurodegeneratieve ziekten) en 30 cognitief gezonde deelnemers.
    E.1.1.1Medical condition in easily understood language
    In total, 170 subjects will participate in this study, including healthy subjects and patients with cognitive complaints or diagnosed with a dementia.
    In totaal worden 170 mensen uitgenodigd voor deze studie, waarbij zowel gezonde deelnemers als mensen met cognitieve klachten of een dementie worden uitgenodigd.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Careful tracer kinetic modelling of specific binding is required especially for assessment of changes in amyloid binding over time or when using pharmacologic interventions designed to lower amyloid binding. In addition, its [18F]-label with a half-life of 110 minutes will enable use in hospitals without an on-site cyclotron, greatly enhancing its clinical applicability. The present study is designed to evaluate tracer kinetics of [18F]AV-45 and to investigate its clinical diangostic value.
    Zorgvuldige tracer kinetische modellering van de specifieke binding van [18F]AV-45 is vooral belangrijk voor de beoordeling van veranderingen in Aß binding over de tijd of bij gebruik tijdens farmacologische interventies ontworpen om Aß binding te verlagen. Bovendien kan [18F]AV-45 met zijn halfwaardetijd van 110 minuten de klinische toepasbaarheid van amyloïd beeldvorming sterk verbeteren. Deze studie is ontworpen om de tracer kinetiek te evalueren en de klinische diangostische waarde van [18F]AV-45 te onderzoeken.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent; - weight >50 kg; - Mini Mental State Examination score ≥ 18.
    - Ondertekend informed consent; - Gewicht >50 kg; - Mini Mental State Examination score ≥ 18.
    E.4Principal exclusion criteria
    Patients who
    1. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan;
    2. Have Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV);
    3. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. 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, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F);
    4. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound);
    5. Have 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;
    6. Have donated blood within 3 months prior to the florbetapir (18F) PET scan day;
    7. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
    8. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
    Patiënten die
    1. Een klinische significante psychiatrische aandoening hebben zodanig dat de behandelend neuroloog/geriater voorkeur hebben om een onderzoek PET-scan uit te sluiten ;
    2. Een klinisch significante besmettelijke ziekte hebben, inclusief Acquired Immunodeficiency Syndrome (AIDS) of Human Immunodeficiency Virus (HIV);
    3. vrouwelijk zijn in de vruchtbare leeftijd en niet chirurgisch steriel, niet afzien van seksuele activiteit of geen betrouwbare methoden van anticonceptie gebruiken. Vruchtbare vrouwen mogen niet zwanger zijn (negatieve serum β-hCG ten tijde van de screening en negatieve urine β-hCG op de dag van de PET scan) of het geven van borstvoeding bij de screening. Vrouwen moeten gedurende 24 uur na toediening van [18F]Flutemetamol vermijden zwanger te worden en moeten akkoord gaan met zich te onthouden van seksuele activiteit of een betrouwbare anticonceptie methoden toepassen, zoals een voorgeschreven pil of spiraaltje;
    4. Een relevante voorgeschiedenis van ernstige medicatieallergie of overgevoeligheid (relevante ernstige drugs allergieën moet worden bepaald door de Principal Investigator of Co-Principal investigator). Als een deelnemer een voorgeschiedenis heeft met ernstige medicatie allergieën kan het gevaarlijk zijn om deel te nemen aan een studie met een nieuw geneesmiddel;
    5. Ooit hebben deelgenomen aan een experimentele studie met een amyloïd targeting agent (bijv. anti-amyloïde immunotherapie, γ-secretase-of γ-secretase-remmers), tenzij kan worden gedocumenteerd dat het subject ontving slechts placebo in de loop van het proces;
    6. bloed hebben gedoneerd binnen 3 maanden voorafgaand aan de florbetapir (18F) PET scan;
    7. experimentele medicatie gebruiken of hebben deelgenomen aan een proef met experimentele medicatie in de laatste 30 dagen voor de PET scan;
    8. een radiofarmaceutische beeldvorming of behandeling procedure hebben ondergaan binnen 7 dagen voorafgaand aan de PET scan;
    E.5 End points
    E.5.1Primary end point(s)
    This study is divided in two sub-studies: a kinetic modelling study and a clinical diagnostic study. The main outcome measures of the kinetic modelling study are the identification the most suitable tracer kinetic method for quantification of [18F]AV-45 and the determination of a validated (simplified) tracer kinetic model for [18F]AV-45 analysis which will be used in the clinical diagnostic study. The outcome measure of the clinical diagnostic study is the diagnostic value of (both visual and quantitative rated) [18F]AV-45 PET scans in a memory clinic patient cohort.
    Deze studie is onderverdeeld in twee deelonderzoeken: een kinetische modellering onderzoek en een klinisch diagnostisch onderzoek. De primaire uitkomstmaten van de kinetische modellering studie zijn de identificatie van de meest geschikte kinetische methode voor kwantificatie van [18F]AV-45 binding en de identificatie van een gevalideerd (vereenvoudigde) kinetisch model voor [18F]AV-45 analyse. Dit vereenvoudigde model zal worden gebruikt voor analyse van het klinische diagnostische onderzoek. De primaire uitkomstmaat van de klinische diagnostische studie is de diagnostische waarde van (zowel visueel als kwantitatief beoordeelde) [18F]AV-45 PET scans in een geheugen polikliniek patiëntencohort.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First, the kinetic modelling substudy will be performed in order to evaluate the most suitable tracer kinetic method for quantification and identify the most suitable kinetic model. After, patient of the clinical diagnostic substudy will be included. The determined kinetic model will be applied on PET data of these memory clinic patient population.
    Eerst zal de kinetische modeliering studie worden uitgevoerd om de de meest geschikte kinetische methode voor kwantificatie van [18F]AV-45 binding en een gevalideerd (vereenvoudigde) kinetisch model voor [18F]AV-45 analyse te bepalen. Hierna zullen de patienten van de klinische diagnostische studie worden geincludeerd, waarbij het eerder ontworpen kinetische model zal worden toegepast op de PET data van deze geheugenkliniek patienten populatie.
    E.5.2Secondary end point(s)
    Secondary study parameters are the concordance of [18F]AV-45 PET with MRI markers (MTA) and with CSF markers (Aβ 1-42, total tau and p-tau 181) will be assessed by binary rating (e.g. ‘normal’ or ‘abnormal’) for each of these measures. Furthermore, at baseline dementia severity and neuropsychological measures will be obtained to allow analysis of associations with continuous measures of cognitive impairment to determine the prognostic value of [18F]AV-45 PET.
    Secundaire studie parameters zijn de concordantie van [18F] AV-45 PET met MRI-markers (MTA) en CSF markers (Aß 1-42, totaal tau en p-tau 181). Dit zal worden gemeten door het vergelijkingen van de binaire beoordeling (bv 'normaal' of 'abnormaal') voor elk van deze markers. Daarnaast zal een neuropsychologisch onderzoek worden afgenomen waardoor continue metingen van cognitieve stoornissen kunnen worden verkregen voor het vaststellen van de prognostische waarde van [18F] AV-45 PET.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be performed after the last patient's last visit in the clinical diagnositc study.
    Evaluatie zal worden uitgevoerd na de laatste visite van de laatste patient van de klinische diagnostische studie.
    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 Yes
    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) Yes
    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.8.5The 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 years3
    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.1.1.1In 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: 140
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients diagnosed with dementia
    Patienten met een diagnose dementie
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    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)
    None
    Geen
    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 Decision2014-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-16
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 04:22:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA