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    The EU Clinical Trials Register currently displays   43857   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).

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    Summary
    EudraCT Number:2012-002303-18
    Sponsor's Protocol Code Number:ISS112
    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:2012-10-18
    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 number2012-002303-18
    A.3Full title of the trial
    The Dutch Flutemetamol in Young Dementia Study
    De Nederlandse Flutemetamol in Vroege Dementie Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dutch study to Flutemetamol in patients diagnosed with dementia with a young onset
    Nederlandse studie naar Flutemetamol in patienten die zijn gediagnostiseerd met dementie op een jonge leeftijd
    A.3.2Name or abbreviated title of the trial where available
    Dutch Flutemetamol Study
    Nederlandse Flutemetamol Studie
    A.4.1Sponsor's protocol code numberISS112
    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 supportGE Healthcare
    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 pointAlzheimercentrum
    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 number00310204440816
    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 nameFlutemetamol (18F)
    D.3.2Product code AH110690 (18F) Injection
    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 INN[18F]flutemetamol
    D.3.9.1CAS number 765922-62-1
    D.3.9.3Other descriptive nameFlutemetamol F-18
    D.3.9.4EV Substance CodeSUB33652
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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
    Young (age of diagnosis ≤ 70 years) patients with (suspicion of) dementia with at least some doubt about etiological diagnosis.
    Jonge (leeftijd bij diagnose ≤ 70 jaar) patienten met (een vermoeden van) dementie met ten minste enige twijfel over de etiologische diagnose.
    E.1.1.1Medical condition in easily understood language
    Young (age of diagnosis ≤ 70 years) patients with (suspicion of) the diagnosis dementia, of which the cause is not fully clear.
    Jonge (leeftijd bij diagnose ≤ 70 jaar) patienten met (een vermoeden van) de diagnose dementie, maar waarvan de oorzaak van de dementie nog niet geheel zeker is.
    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
    1. To investigate the clinical value of [18F]Flutemetamol PET in patients with young onset dementia in terms of
    a. change in (level of confidence of) diagnosis;
    b. impact on patient healthcare management;
    c. diagnostic accuracy of final diagnosis at 2 years follow-up;
    d. cost-effectiveness.
    1. De klinische waarde van [18F]Flutemetamol PET onderzoeken bij patiënten met vermoeden van dementie op jonge leeftijd in termen van
    a. verandering in (de mate van zekerheid van) de diagnose;
    b. impact op het gezondheidszorg management van de patient;
    c. diagnostische nauwkeurigheid van de definitieve diagnose na 2 jaar follow-up;
    d. kosteneffectiviteit.
    E.2.2Secondary objectives of the trial
    1. To assess the concordance of [18F]Flutemetamol PET with established biomarkers acquired from CSF and MRI;
    2. To assess the prognostic value of [18F]Flutemetamol PET.
    1. De concordantie van [18F]Flutemetamol PET beoordelen met biomarkers uit CSF (Aß 1-42, totaal tau en p-tau 181) en MRI (atrofie mediale temporale kwab);
    2. De prognostische waarde van [18F] Flutemetamol PET beoordelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent;
    - (suspicion of) dementia diagnosis;
    - Weight >50 kg;
    - Mini Mental State Examination score ≥ 18.
    - Ondertekend informed consent;
    - (vermoeden van) diagnose dementie;
    - Gewicht >50 kg;
    - Mini Mental State Examination score ≥ 18.
    E.4Principal exclusion criteria
    Patients who
    - are considered medically unstable;
    - require additional laboratory tests or workup between enrolment and completion of the PET scan;
    - have a clinically significant infectious disease, including Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection;
    - are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days prior to the PET scan;
    - 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;
    - have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the PET scan;
    - are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-hCG at the time of screening and negative urine β-hCG on the day of imaging) or breast feeding at screening. Females 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 [18F]Flutemetamol;
    - are claustrophobic;
    - have abnormalities on MRI other than white matter changes or an incidental small lacunar lesion;
    - have donated blood within 3 months before the scan day;
    - have metal objects in or around the body (braces, pacemaker, metal fragments).
    Patiënten die
    - worden beschouwd als medisch instabiel;
    - Extra laboratoriumtests of diagnostisch onderzoek vereisen tussen de inschrijving en voltooiing van de PET scan;
    - Een klinisch significante besmettelijke ziekte hebben, inclusief Acquired Immunodeficiency Syndrome (AIDS) of Human Immunodeficiency Virus (HIV);
    - experimentele medicatie gebruiken, of hebben deelgenomen aan een proef met experimentele medicatie in de laatste 30 dagen voor de PET scan;
    - ooit hebben deelgenomen aan een experimenteel onderzoek met een amyloïd targeting agent (bv. anti-amyloid immunotherapie, γ-secretase-of γ-secretase-remmer), tenzij kan worden aangetoond dat de proefpersoon uitsluitend een placebo toegediend kreeg;
    - een radiofarmaceutische beeldvorming of behandeling procedure hebben ondergaan binnen 7 dagen voorafgaand aan de PET scan;
    - 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;
    - claustrofobisch zijn;
    - afwijkingen op de MRI laten zien, anders dan wittestof afwijkingen/veranderingen of een incidentele kleine lacunaire laesies.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measure is the clinical value of [18F]Flutemetamol PET, which can be subdivided into four outcome measures. First, the change in (the level of confidence in) the diagnosis as assessed by the clinician after the disclosure of the PET results will be measured. Secondly, the impact on future patient management as measured using additional ancillary investigations, prescription of medication and use of health care will be measured. Third, the diagnostic accuracy for final diagnosis defined by a consensus panel of clinicians at 2 years follow-up (used as a reference diagnosis) will be estimated. Fourth, cost-effectiveness will be assessed using questionnaires that enables quality of life and care related costs calculation.
    De belangrijkste uitkomstmaat is de klinische waarde van [18F]Flutemetamol PET; deze kan worden onderverdeeld in vier onderdelen. Ten eerste zal de verandering in (de mate van zekerheid van) de diagnose zoals beoordeeld door de arts na de bekendmaking van de PET-resultaten worden gemeten. Ten tweede zal de impact van de PET resultaten op de toekomstige behandeling van de patiënt worden bepaald, gemeten met behulp van extra aanvullende vragen gericht op het voorschrijven van medicatie en het gebruik van de gezondheidszorg. Ten derde zal de diagnostische nauwkeurigheid worden vastgesteld met behulp van een definitieve diagnose welke wordt vastgesteld door een consensus panel van clinici na twee jaar follow-up (als referentie diagnose). Ten vierde zal kosten-effectiviteit worden beoordeeld met behulp van vragenlijsten die kwaliteit van leven en zorggerelateerde kosten meten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation wil be executed after the last patient’s last visit.
    Een evaluatie wordt uitgevoerd na het laatste bezoek van de laatste patient.
    E.5.2Secondary end point(s)
    The concordance of [18F]Flutemetamol PET with CSF markers (Aβ 1-42, total tau and p-tau 181) and MRI markers (atrophy medial temporal lobe) will be assessed by binary rating (e.g. ‘normal’ or ‘abnormal’) for each of these measures.
    Furthermore, the prognostic value of [18F]Flutemetamol will be measured using (repeated) cognitive measures (Mini Mental State Examination (MMSE) and the Cambridge Cognitive Test (CAMCOG)) obtained at baseline and at 1 and 2 year follow-up.
    De concordantie van [18F] Flutemetamol PET met CSF markers (Aß 1-42, totale tau en gefosforyleerd tau) en MRI markers (atrofie van de mediale temporaal kwab) zal worden beoordeeld met behulp van een binaire beoordeling (bv 'normaal' of 'abnormaal') van elk van deze maten. Bovendien zal de prognostische waarde van [18F] Flutemetamol worden gemeten met behulp van (herhaalde) cognitieve maten (Mini Mental State Examination (MMSE) en Cambridge Cognitive Test (CAMCOG)) gemeten op baseline en na 1 en 2 jaar follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Niet van toepassing.
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    The end of the study is defined as the last patient’s last visit.
    Het einde van de studie is gedefinieerd als het laatste bezoek van de laatste patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 160
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 with an incurable disease (dementia)
    patienten met een ongeneeslijke ziekte (dementie)
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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 Decision2012-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
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