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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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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    EudraCT Number:2020-002672-12
    Sponsor's Protocol Code Number:73807
    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:2020-10-08
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002672-12
    A.3Full title of the trial
    Frontotemporal dementia Imaging of Neuroinflammation, Degeneration and Microglia-Related Effects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of neuroinflammation in frontotemporal dementia by means of PET-MRI
    Beeldvorming van neuroinflammatie in frontotemporale dementie met behulp van PET-MRI
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number73807
    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 SponsorErasmus 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 supportZonMw
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GD
    B.5.4Telephone number+310107043485
    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]DPA-714
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    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.3.8INN - Proposed INN[18F]DPA-714
    D.3.9.3Other descriptive name[18-F]DPA-714
    D.3.9.4EV Substance CodeSUB191174
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number225 to 275
    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
    Frontotemporal dementia (FTD), including symptomatic patients and presymptomatic individuals with genetic mutations predisposing to FTD at a later stage in life.
    E.1.1.1Medical condition in easily understood language
    Frontotemporal dementia
    Frontotemporale dementie
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching goal of this pilot study is to test the novel TSPO [18F]DPA-714 tracer as a marker of microglial activation in FTD. Within this framework, our primary objective is to assess the quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls.
    E.2.2Secondary objectives of the trial
    i. To compare the quantity and regional distribution of [18F]DPA-714 binding in symptomatic and presymptomatic carriers of FTD genetic mutations;
    ii. To explore the relationship between [18F]DPA-714 binding, clinical presentation and progression, and other markers of neurodegeneration (MRI, CSF/serum biomarkers).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Able to tolerate the [18F]DPA-714 PET-MRI scan procedures and to make an informed decision to participate in this study
    - Symptomatic patients must meet clinical criteria for FTD clinical syndromes
    - Presymptomatic individuals and healthy controls must show no objective evidence of cognitive impairment
    E.4Principal exclusion criteria
    - Has contraindications for MRI scanning, e.g. metal objects in the body, claustrophobia
    - Has evidence of structural brain abnormalities that are likely to interfere with the interpretation of PET scan
    - Has one or more comorbidities that may interfere with the outcomes of the study (e.g. significant immune disease, neurological disease, CNS malignancy)
    - Has a history of moderate or severe traumatic brain injury
    - Has made use of immunomodulatory or immunosuppressive therapy in the 3 months prior to the scan
    - Has any disease or uses medication that may compromise the function of the body systems and could interfere with the metabolism of the radiotracer or the interpretation of the results
    - Has an unstable medical condition
    - Is pregnant or breastfeeding
    - Has a history of severe drug allergy or hypersensitivity
    - Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when the total yearly radiation exposure exceeds 10 mSv if participating in this protocol
    - Is a low-affinity binder for the tracer based on the rs6971 TSPO polymorphism
    - Has a present or past history of alcohol and/or drug abuse
    - Makes use of benzodiazepines and is not able to suspend their use during the week prior to the PET scan
    E.5 End points
    E.5.1Primary end point(s)
    The quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls. [18F]DPA-714 binding will be measured as standardized uptake value ratios using an unaffected brain region as reference region.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated after PET-MRI data collection. Each participant will undergo one single scan and will receive one administration of the radiotracer immediately prior to the scan.
    E.5.2Secondary end point(s)
    - Comparison of [18F]DPA-714 binding between patients and presymptomatic gene carriers
    - Comparison of [18F]DPA-714 binding between presymptomatic gene carriers and healthy controls (i.e. non-carriers)
    - Correlation of [18F]DPA-714 binding with other MRI measures of neuroinflammation and neurodegeneration
    - Correlation of [18F]DPA-714 binding with measures of clinical severity and neuropsychological performance
    - Correlation of [18F]DPA-714 binding with levels of CSF and/or blood biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will also be evaluated after PET-MRI data collection. Scanning by means of PET-MRI will enable us to obtain [18F]DPA-714 binding data as well as acquisition of MRI sequences relevant for neuroinflammation and neurodegeneration (T1, T2, T2*, FLAIR, DTI). Clinical and neuropsychological data are available for FTD patients and presymptomatic carriers, who have been seen and/or diagnosed at the Alzheimer Center and are enrolled in ongoing research protocols. In a subset of patients, fluid samples (CSF, blood) are available for parallel analysis of neuroinflammatory markers and correlation with PET-MRI data.
    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. 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 years2
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state32
    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)
    All participants will be invited for a clinical follow-up visit one year after participation in the study. Subjects who choose to withdraw from the study or who experienced adverse effects will be seen by a competent physician, if necessary.
    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 Decision2020-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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