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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   41498   clinical trials with a EudraCT protocol, of which   6826   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-004230-10
    Sponsor's Protocol Code Number:15-14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004230-10
    A.3Full title of the trial
    Validating in vivo quantification of tau with [18F]AV-1451 PET
    Het valideren van in vivo quantificatie van tau met [18F]AV-1451 PET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measuring the amount of tau binding
    Het meten van de mate van tau-binding
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number15-14
    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
    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 Pharmaceuticals
    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
    B.5.2Functional name of contact pointDept of Radiology Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.4Telephone number0031204441948
    B.5.5Fax number0031204444329
    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 name18F-AV-1451
    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 INNnot applicable
    D.3.9.1CAS number 152201-90-6
    D.3.9.2Current sponsor code18F-AV-1451
    D.3.9.3Other descriptive nameT807
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number74
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Alzheimer's Disease (AD)
    ziekte van Alzheimer
    E.1.1.1Medical condition in easily understood language
    dementia, Alzheimer's Disease
    dementie, ziekte van Alzheimer
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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
    To validate the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451
    Het valideren van het eerder gedefineerde versimpelde tracer kinetisch model, waarmee specifieke binding van [18F]AV-1451 wordt gekwantificeerd
    E.2.2Secondary objectives of the trial
    To assess test-retest variability of quantitative [18F]AV-1451 outcome measures
    Het bepalen van de test-hertest variabiliteit van kwantitatieve [18F]AV-1451 uitkomstmaten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A healthy control subject must meet all of the following criteria:
    1. At least 50 years of age;
    2. Have no evidence of cognitive impairment as indicated by a cognitive neurologist;
    3. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures.

    Probable AD subjects must meet the following inclusion criteria:
    1. At least 50 years of age;
    2. Have a clinical diagnosis of probable AD (McKhann, 2011) and are part of the Amsterdam Dementia Cohort (Flier et al. 2014);
    3. Have a Mini Mental State Examination (MMSE) of 18 or higher;
    4. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV-1451 PET scan and blood sampling procedures.
    Gezonde controles moeten voldoen aan de volgende criteria:
    1. Tenminste 50 jaar oud
    2. Geen aanwijzingen voor cognitieve achteruitgang, vastgesteld door een cognitief neuroloog
    3. Volgens de Principle Investigator in staat om de [18F]AV-1451 scan procedures en arteriële sampling te kunnen ondergaan

    Proefpersonen met 'probable' ziekte van Alzheimer moeten voldoen aan de volgende criteria:
    1. Tenminste 50 jaar oud
    2. Klinische diagnose van 'probable' ziekte van Alzheimer (McKhann, 2011) en deelname aan het Amsterdams Dementie Cohort (Flier et al. 2014)
    3. Een Mini Mental State Examination (MMSE) van 18 of hoger;
    4. Volgens de Principle Investigator in staat om de [18F]AV-1451 scan procedures en arteriële sampling te kunnen ondergaan
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study if he or she:

    1. Has contra indications for MRI scanning and therefore can not receive brain MRI
    2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of a PET scan;
    3. Has a history of severe traumatic brain injury (TBI);
    4. Has a hemoglobin test (Hb) result of < 8 in males and < 7 in females;
    5. Is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening.
    6. Has 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.);
    7. Has current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec). If QTc is >450 at screening, the principal investigator may consult with Avid for approval to enroll;
    8. Has a history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT syndrome) or is taking drugs that are known to cause QT-prolongation;
    9. Has donated blood within 6 months prior to the [18F]AV-1451 PET scan day;
    10. Has ever participated in an experimental study with a tau or amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial.
    11. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv.
    1. Contra-indicaties voor een MRI-scan, en kan daardoor geen MRI-scan ontvangen
    2. Aanwijzingen voor structurele afwijkingen op de MRI, zoals een herseninfarct of ruimte-innemend proces, waardoor interpretatie van de PET-scan bemoeilijkt wordt
    3. Voorgeschiedenis van ernstig traumatisch hersenletsel (traumatic brain injury, TBI)
    4. Hemoglobine (Hb) van <8 (mannen) of <7 (vrouwen)
    5. Potentieel vruchtbare vrouwen, niet chirurgisch gesteriliseerd, die zich niet onthouden van seksuele activiteit of geen gebruik maken van betrouwbare anticonceptie. Potentieel vruchtbare vrouwen mogen niet zwanger zijn of borstvoeding geven.
    6. Voorgeschiedenis met ernstige medicijnenallergie of hypersensitiviteit
    7. Huidige klinisch significante cardiovasculaire ziekte of klinisch significante afwijkingen op ECG
    8. Voorgeschiedenis met risicofactoren voor Torsades de Pointes (hartfalen, hypokaliëmie, positieve familie-anamnese voor Long QT Syndrome) of wanneer er medicijnen worden ingenomen die de QT-tijd kunnen verlengen
    9. Binnen 6 maanden voorafgaand aan het onderzoek bloed gedoneerd
    10. Eerder deelgenomen aan een experimentele studie met een tau of amyloid targeting agent, behalve als kan worden aangetoond dat patiënt alleen placebo kreeg toegediend
    11. Voorgaand radiofarmacon toegediend gekregen binnen 6 halfwaardetijden OF wanneer de totale jaarlijkse stralingsdosis meer dan 10 mSv is
    E.5 End points
    E.5.1Primary end point(s)
    Test-retest variability of [18F]AV-1451 binding
    Test-hertest variabiliteit van [18F]AV-1451 binding
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous PET scan from 0-60 and 80-130 minutes post injection and continuous arterial blood draw 0-60 minutes post injection. Repeat after 1 week.
    Continue PET-scan van 0-60 en 80-130 minuten na injectie en continue ateriële bloedafname 0-60 minuten post-injectie. Herhaling na 1 week.
    E.5.2Secondary end point(s)
    Not applicable
    Niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and after 1 week follow up
    Op baseline en na 1 week
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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. 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.8.3 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state15
    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)
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-08
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