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    Summary
    EudraCT Number:2021-005024-37
    Sponsor's Protocol Code Number:202100647
    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:2022-01-19
    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 number2021-005024-37
    A.3Full title of the trial
    Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of a novel PET tracer [18F]MC225 to measure the function of P-glycoprotein, a transporter at the blood brain barrier, in neurodegenerative disease
    A.4.1Sponsor's protocol code number202100647
    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 Medical Center Groningen
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointP. Mossel
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailp.mossel@umcg.nl
    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]MC225
    D.3.4Pharmaceutical form Injection/infusion
    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]MC225
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor code[18F]MC225
    D.3.9.3Other descriptive name[18F]MC225
    D.3.9.4EV Substance CodeSUB253551
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number180 to 220
    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
    - Alzheimer's disease
    - Mild Cognitive Impairment
    - Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    - Alzheimer's disease - Dementia
    - Mild Cognitive Impairment
    - Parkinson's disease
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    P-glycoprotein (P-gp) is a transporter at the blood-brain barrier, responsible for the efflux of neurotoxic substances out of the brain. Both the onset of Alzheimer's disease (AD) and Parkinson's disease (PD) are associated with a decrease in P-gp function and P-gp inducers are considered to be potential treatment. To measure the effect of P-gp inducers, [18F]MC225 will be studied under pathological conditions first. Results will be compared with results obtained from healthy volunteers in a previous study.
    E.2.2Secondary objectives of the trial
    1. Evaluation of blood-brain barrier integrity using [18F]MC225 and MRI VAI sequence in Alzheimer’s disease, MCI and Parkinson’s disease.

    2. Evaluation of perfusion measurements using both [15O]H2O PET and MRI (DSC, DCE) to simplify the scan protocol in further [18F]MC225 studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Alzheimer's disease
    - Patients who meet the criteria for Alzheimer’s disease and are mentally competent to give informed consent:
    I. Documented cognitive decline
    II. Progressive course of cognitive decline
    III.Complaints in the following areas
    a. memory
    b. language
    c. visuospatial functions
    d. executive functions
    IV. Absence of cerebrovascular disease or signs of other neurodegenerative disease except for Alzheimer’s disease.

    and show biomarkers positive for AD:
    I. amyloid-depositions in the brain showed by low Aβ42 in CSF and/or positive amyloid imaging at a PIB-PET
    II. Neuronal damages showed by increased tau/ptau in CSF or;
    decreased FDG uptake at the parietotemporal lobe or;
    disproportional atrophy of the medial, basal and lateral temporallobes, generalised atrophy and/or biparietal atrophy.
    The diagnosis Alzheimer’s disease is made by a multidisciplinary team consisting of neurologists, psychologists and internists.

    2. Mild Cognitive Impairment
    Patient is not meeting the criteria for Alzheimers disease, but shows:
    - Decline in one or more cognitive domains (showed by a neuropsychological examination)
    - No interference of symptoms with daily life
    The diagnosis Alzheimer’s disease is made by a multidisciplinary team consisting of psychiatrists, neurologists, psychologists and internists.
    - Absence of cerebrovascular disease or signs of other neurodegenerative disease except for MCI
    The diagnosis MCI is made by a multidisciplinary team consisting of neurologists, psychologists and internists

    3. Parkinson's disease
    Symptoms of bradykinesia and one of the following symptoms (25):
    - rigidity
    - rest tremor
    - instability (not related to visual, cerebellar or proprioceptive disorders)
    - no other explanation for abovementioned symptoms at MRI
    - The diagnosis Parkinson’s disease is made by a neurologist
    - Absence of cerebrovascular disease or signs of other neurodegenerative disease except for Parkinson’s disease
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - History of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia
    - Claustrophobia

    Use of medication with known P-gp influence, according to the Farmacotherapeutisch Kompas:
    - Digoxine
    - Dabigatran
    - Everolimus
    - Verapamil
    - Tacrolimus
    - Rosuvastatin
    - Lercanidipin
    - Repaglinide
    - Aliskiren
    - Aminoglycosides
    - Vancomycine
    - NSAIDs
    - Acyclovir
    - Trimethoprim
    - Amfotericine B
    - Ciprofloxacine
    - H2 receptor antagonists
    - Methotrexate
    - St. John’s Wort
    - Loperamide

    Exclusion Criteria contrast-enhanced MRI:
    - Metallic objects or fragments placed in the body
    - Artificial metal joints or implants
    - Pacemaker
    - Clips/Stents in blood vessel
    - Claustrophobia
    - a history of mastocytosis
    - Pregnancy or breastfeeding
    - Kidney failure (< 45 ml/min)
    - Allergy to MR contrast or dye
    - Tattoo (>20cm)
    E.5 End points
    E.5.1Primary end point(s)
    Brain regional uptake values of [18F]MC225 as a measure of P-gp function in Alzheimer's disease, Mild Cognitive Impairment and Parkinson's disease
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after the last PET-scan.
    E.5.2Secondary end point(s)
    MRI perfusion (DSC, DCE) parameters to compare with results of the [15O]H2O-PET to enable correction for perfusion effects interfering with outcome parameters of [18F]MC225.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after the last PET-scan.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    neurodegenerative disease compared with healthy volunteers of a previous study
    E.8.2.4Number of treatment arms in the trial4
    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
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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)
    normal treatment of condition
    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 Decision2022-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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