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    Summary
    EudraCT Number:2013-003733-15
    Sponsor's Protocol Code Number:B-003
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-24
    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 number2013-003733-15
    A.3Full title of the trial
    The Dutch CSF and PET Biomarker Concordance of Alzheimer’s Disease pathology study
    De Nederlandse CSF en PET Biomarker Concordantie van Alzheimer pathologie studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dutch Study on biological markers of Alzheimer's Disease
    Nederlandse studie naar biologische markers van de ziekte van Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    Dutch Study on CSF and PET Biomarker Concordance
    Nederlandse studie naar CSF en PET biomarker concordantie
    A.4.1Sponsor's protocol code numberB-003
    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.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 supportMERCK
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGEHC
    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 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 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
    Patients visiting the VUmc Alzheimer Center with objective cognitive complaints or diagnosed with Alzheimer's Disease.
    Patiënten die het VUmc Alzheimercentrum bezoeken met milde cognitieve stoornissen of de diagnose ziekte van Alzheimer
    E.1.1.1Medical condition in easily understood language
    Patients visiting the VUmc Alzheimer Center with complaints or diagnosed with Alzheimer's Disease
    Patiënten die het VUmc Alzheimercentrum bezoeken met geobjectiveerde klachten of die een diagnose ziekte van Alzheimer ghebben gekregen
    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
    To assess the concordance of [18F]Flutemetamol PET across a range of detergent-based CSF tau:Abeta 1-42 ratio assay values across the range of AD pathology in controls, MCI subjects and AD patients.
    De concordantie bepalen tussen [18F]Flutemetamol PET en een reeks van CSF tau:abeta1-42-ratio waarden in MCI patiënten, AD patiënten en controle proefpersonen.
    E.2.2Secondary objectives of the trial
    To compare the concordance between [18F]Flutemetamol PET and the detergent-based CSF assay and the well established abeta 1-42, tau and p-tau assays used routinely in VUmc in the same range of patients
    De concordantie ebepalen tussen [18F]Flutemtamol PET en CSF op basis van de eerder vastgestelde afkapwaarden voor abeta 1-42, tau and p-tau zoals routinematig gebruikt in VUmc in MIC patienten, AD patienten en controle proefpersonen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject :
    - must be ≥ 50 to ≤ 85 years of age.
    - is seen at the memory clinic of the VUmc Alzheimer Center upon referral of another clinician and follows the routine screening procedure
    - must have results of routine clinical laboratory tests including a complete blood count (CBC) a physical examination, vital signs within normal limits or clinically acceptable to the investigator within 60 days prior to enrollment.
    - (or legal representative) must have signed (the study specific)informed consent form, which covers the scope and nature of this agreement before screening assessments.
    - (or legal representative) must have checked "Yes" to the following questions located on page 2 of the general informed consent form of the Alzheimer Center :
    o I give my consent for the storage and use of my coded medical information.
    o I give my consent for the collection, storage and provision of coded samples of my cerebrospinal fluid to the Alzheimer’s Center Biobank and the String of Pearls Initiative Parelsnoer Initiatief for the purposes outlined in the information.
    Elke deelnemer:
    - is ≥ 50 tot ≤ 85 jaar oud.
    - Wordt gezien bij de herinnering kliniek van het VUmc Alzheimercentrum op verwijzing van een andere arts en volgt de routinematige screening procedure
    - Moeten de resultaten van routine klinische laboratoriumtests hebben ondergaan, waaronder een complete bloedbeeld (CBC) een lichamelijk onderzoek, vitale functies binnen de normale grenzen of klinisch aanvaardbaar voor de onderzoeker binnen 60 dagen voorafgaand aan inclusie;
    - (Of wettelijke vertegenwoordiger) moet het informed consent formulier van deze studie hebben ondertekend voorafgaand aan de studie;
    - (Of wettelijke vertegenwoordiger) moet "Ja" hebben geantwoord op de volgende vragen op pagina 2 van het algemene informed consent formulier van het Alzheimercentrum
    o Ik geef mijn toestemming voor de opslag en het gebruik van mijn gecodeerde medische informatie.
    o Ik geef mijn toestemming voor het verzamelen, opslaan en verstrekken van gecodeerde monsters van mijn hersenvocht aan het Alzheimer Centrum Biobank en het Parelsnoer Initiatief Parelsnoer Initiatief voor de in het informatieve doeleinden.
    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 which may can affect Flutemetamol PET scan reading;
    - have donated blood within 3 months before the scan day;
    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 welke mogelijk effect kunnen hebben op het beoordelen van de Flutemetamol PET scan.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measures are the concordance (diagnostic agreement of reported brain amyloid status) between [18F]Flutemetamol PET and a range of CSF tau:abeta1-42 ratio values that meet independently-defined minimum criteria for a binary classifier of AD (sensitivity ≥ 0.8, specificity >0.6). This range of CSF threshold values will be determined in a separate study currently underway, using additional independently collected CSF samples. Secondary outcome is the concordance between PET amyloid status and routine CSF abeta 1-42, total tau and p-tau 181 values.
    De belangrijkste uitkomstmaten zijn de concordantie (diagnostische overeenkomst van de gerapporteerde hersenen amyloid status) tussen [18F] Flutemetamol PET en een reeks van CSF tau: abeta1-42-ratio waarden die voldoen aan de onafhankelijk gedefinieerde minimale criteria voor een binaire classificatie van AD (gevoeligheid ≥ 0.8, specificiteit> 0.6). De reeks van CSF afkapwaarden zullen worden bepaald in een afzonderlijke studie die momenteel wordt uitgevoerd en aanvullend gebruikt maakt van onafhankelijk verzamelde CSF monsters.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be executed after the last patient's last visit
    Een evaluatie zal worden uitgevoerd na het laatste bezoek van de laatste patiënt
    E.5.2Secondary end point(s)
    Secondary outcome is the concordance between PET amyloid status and routine CSF abeta 1-42, total tau and p-tau 181 values.
    Secundaire uitkomst is de concordantie tussen PET-amyloid status en routine CSF Abeta 1-42, totaal tau en p-tau 181 waarden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be executed after the last patient's last visit
    Een evaluatie zal worden uitgevoerd na het laatste bezoek van de laatste patiënt
    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.8.3 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 Yes
    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 years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state90
    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 Decision2013-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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