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    The EU Clinical Trials Register currently displays   42151   clinical trials with a EudraCT protocol, of which   6931   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-004671-12
    Sponsor's Protocol Code Number:s55892
    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:2014-05-20
    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 number2013-004671-12
    A.3Full title of the trial
    Predictive value of biomarkers in patients with amnestic mild cognitive impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Predictive value of biomarkers in patients with amnestic mild cognitive impairment
    A.4.1Sponsor's protocol code numbers55892
    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 SponsorUniversity of Leuven
    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 supportPiramal Imaging Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leuven
    B.5.2Functional name of contact pointMemory Clinic
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailrik.vandenberghe@uzleuven.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 Yes
    D.2.1.1.1Trade name NeuraCeq
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Imaging Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNeuraceq
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Mild cognitive impairment
    E.1.1.1Medical condition in easily understood language
    Mild cognitive impairment
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    We will test the predictive value of baseline flutemetamol capture for longitudinal change in amyloid load measured using PET in MCI cases.
    Second, we will compare CSF Aβ42 and amyloid PET for classification of amyloid-positive and amyloid negative cases. Third, we will compare the predictive value of CSF AD biomarkers Aβ42, T-tau and P-tau181P with that of amyloid imaging for MCI cases that progress to Alzheimer's disease.
    E.2.2Secondary objectives of the trial
    Our secondary objectives include the evaluation of whether a change in amyloid deposition (measured by CSF Aβ42 or SUVR) over a 1 year period predicts cognitive decline over a 2 year time period and whether both measures contribute independently to this decline.
    Further, we will analyze the predictive value of classical AD biomarkers changes after one year on the progression of cognitive change after 2 years. We will also explore the correlation of baseline exploratory candidate biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female and between ≥ 55 and ≤ 85 years of age on the day of signing the consent form.
    2. If female, patient is not of reproductive potential (two years post-menopausal or surgically sterile).
    4. Patient has a subjective memory concern as reported by subject, study partner, or clinician.
    5. Patient has an abnormal memory function documented by scoring within the
    education adjusted ranges on the CANTAB memory performance (≥ -1SD).
    6. Patient has a Global Clinical Dementia Rating score of 0 or 0.5.
    7. In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
    8. Patient has at least six years of education, or work history sufficient, in the investigator’s opinion, to exclude mental retardation.
    9. Patient is fluent in written and verbal Dutch.
    E.4Principal exclusion criteria
    1. Patient has a history or current evidence of a neurological disorder, that in the opinion of the primary investigator may contribute to the subject's cognitive impairment, including, but not limited to:
    ● Large-vessel stroke,
    ● epilepsy,
    ● Parkinson’s disease,
    ● progressive supranuclear palsy,
    ● Huntington’s disease,
    ● amyotrophic lateral sclerosis,
    ● multiple sclerosis,
    ● CNS infection,
    ● significant head trauma with loss of consciousness,
    ● Normal pressure hydrocephalus

    2. Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions on baseline MRI scan that may contribute to the cause of the memory impairment in the opinion of the investigator. Vascular white matter lesions or other signs of microangiopathy will not be considered an exclusion.
    3. Patient has a history within 6 months prior to screening visit or current evidence of a psychotic disorder or a major untreated depressive disorder.
    4. Patient has a history of malignancy ≤5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year, and who are deemed at low risk for recurrence by her/his treating physician.
    5. Patient has a history or current evidence of any potentially known clinically significant condition , therapy, lab abnormality or other circumstance that in the opinion of the investigator might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
    6. Patients currently use specific psychoactive medications (neuroleptics, chronic anxiolytics, tricyclic antidepressants, antiepileptics, anticholinergics etc.). Stable dose trazodone, mirtazapine or low dose benzodiazepines prescribed for mild insomnia is allowed.
    7. Patients currently use antithrombotics with the exception of acetyl salicylic acid (exclusionary for lumbar puncture).
    8. Cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen.
    9. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV
    criteria)
    10. Patient is currently participating or has participated in a study with an investigational compound or neuropsychological measures within 30 days of signing informed consent.
    11. Subject has any magnetizable metal prostheses, implants or foreign objects that could pose a hazard during MRI scans.
    E.5 End points
    E.5.1Primary end point(s)
    Since this study is not interventional, no end points are defined.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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) 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.8.3 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
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    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 No
    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 state40
    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
    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 Decision2014-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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