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    Summary
    EudraCT Number:2018-002343-29
    Sponsor's Protocol Code Number:CRCSV2A18
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002343-29
    A.3Full title of the trial
    Synaptic modifications in subjective cognitive decline. A study using [18F]UCB-H, a synaptic vesicle 2A radiotracer.
    Modifications synaptiques lors du déclin cognitive subjectif. Une étude avec le [18F]UCB-H, un radiotraceur de la protéine SV2A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Positron emission study of cerebral synaptic density in participants with subjective memory decline
    Etude en tomographie à émission de positons de la densité synaptique cérébrale chez des participants avec trouble de mémoire subjecif
    A.4.1Sponsor's protocol code numberCRCSV2A18
    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 SponsorService of Neurology, CHU Liege
    B.1.3.4CountryBelgium
    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 supportGIGA-CRC ULiège
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGIGA-Cyclotron Research Centre ULiege
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressAllée du 6 Aout 8
    B.5.3.2Town/ cityLiege
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.6E-maileric.salmon@uliege.be
    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 name[18F]UCB-H
    D.3.2Product code [18F]UCB-H
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1774352-40-7
    D.3.9.2Current sponsor code[18F]UCB-H
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    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.IMP: 2
    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 VIZAMYL
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameVIZAMYL
    D.3.2Product code EMEA/H/C/002557
    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 INNflutemetamol (18F)
    D.3.9.1CAS number 765922-62-1
    D.3.9.3Other descriptive name- USAN : flutemetamol F 18 - company name : [18F]AH110690, [18F]GE067, [18F]flutemetamol
    D.3.9.4EV Substance CodeSUB33652
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number360 to 440
    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
    Neurodegenerative Cognitive Disorder
    Trouble Cognitif Neurodégénératif
    E.1.1.1Medical condition in easily understood language
    Neurodegenerative Cognitive Disorder
    Trouble Cognitif Neurodégénératif
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10048598
    E.1.2Term Cognitive disorders
    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
    To study cerebral synaptic loss with PET and [18F[UCB-H as a very early marker of neurodegenerative cognitive disorder, according to their brain amyloid load studied with PET and [18F]flutemetamol
    Etudier la perte synaptique cérébrale en TEP avec le radiotraceur [18F]UCB-H, comme marqueur très précoce d'un trouble cognitif neurodégénératif, en fonction de leur charge cérébrale en amyloide, mesurée par TEP et [18F]flutemetamol
    E.2.2Secondary objectives of the trial
    To compare PET and MRI as early biomarkers of synaptic loss in neurodegenerative cognitive disorder
    Comparer les techniques de TEP et de RMN comme marqueur précoce de perte synaptique dans les troubles cognitifs neurodégénératifs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy eledrly participants (50 to 90 years old), with and without cognitive complaints, with neuropsychological performance in the normal range. A relative is available to provide information on cognitive functioning of the participant.
    Participant âgé "normaux" (agés de 50 à 90 ans), avec et sans plaintes cognitives, avec des performances neuropsychologiques normales. Un proche est disponible pour donner des informations sur le fonctionnement cognitif du participant.
    E.4Principal exclusion criteria
    Systemic disease, cancer, associated vascular pathology, major psychiatric disease, neurological conditions or medications significantly affecting cognition. Exclusion conditions for MRI.
    Maladies systémiques, cancer, pathologies vasculaires significatives, affections psychiatrique, conditions neurologique, medicaments affectant la cognition. Crtères d'exclusion pour la réalisation d'un examen d'imagerie par résonance magnétique nucléaire (IRM).
    E.5 End points
    E.5.1Primary end point(s)
    We hypothesize to find negative correlation between the severity of subjective memory complaints and synaptic activity, and a positive correlation between memory test results (withing the range of normality) and synaptic activity in the MTL. Data will be analysed in « amyloid-positive » and « amyloid-negative » participants, and changes over 18 months will be analysed, looking for evolution of synaptic loss according to initial synaptic density and brain amyloid accumulation
    Relations entre plaintes cognitives et performance cognitive et la densité synaptique dans le lobe temporal médial. Les résultats seront stratifiés en fonction de la charge amyloide cérébrale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (1) Acquisition of data for 50 participants, (2) last inclusion in the trial (T1) and (3) last follow-up visit (T2)
    Acquisition des données pour 50 participants, dernière inclusion dans l'étude (T1) et dernière visite de suivi (T2)
    E.5.2Secondary end point(s)
    As second end point, we will search for a possible influence of MRI measures on the previous relationship, looking for mediation of remote connectivity between MTL and other brain structures (for example in the default mode network) to influence subjective awareness of cognitive decline and possible cognitive performance.
    Influence des mesures de neurodégénérescence et de connectivité obtenues en IRM sur la conscience des troubles et les performances cognitives
    E.5.2.1Timepoint(s) of evaluation of this end point
    See primary end point
    Voir l'objectif primaire
    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 Yes
    E.6.13.1Other scope of the trial description
    Physiopathological
    Physiopathologique
    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) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.2.3.1Comparator description
    Physiopathologique
    Physiopathological
    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
    Dernière visite du dernier sujet
    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 months
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state100
    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)
    Follow up in the Memory Clinic, Service of Neurology, CHU Liege
    Suivi dans la Clinique de la Mémoire, Service de Neurologie, CHU de Liège
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-11
    P. End of Trial
    P.End of Trial StatusOngoing
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