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    Summary
    EudraCT Number:2022-002481-32
    Sponsor's Protocol Code Number:InflamAD
    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:2023-04-11
    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 number2022-002481-32
    A.3Full title of the trial
    Imaging inflammation in Alzheimer's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging inflammation in Alzheimer's Disease
    Beeldvorming van neuroinflammatie in de ziekte van Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    InflamAD
    A.4.1Sponsor's protocol code numberInflamAD
    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 SponsorAmsterdam UMC VUmc
    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 supportAlzheimer Nederland
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC VUmc
    B.5.2Functional name of contact pointdept. Radiology & Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailr.rikken@amsterdamumc.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[11C]SMW139
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Amyloid-beta positive individuals across the Alzheimer's disease continuum and amyloid-beta negative individuals without cognitive complaints
    E.1.1.1Medical condition in easily understood language
    Amyloid-beta positive individuals across the Alzheimer's disease continuum and amyloid-beta negative individuals without cognitive complaints
    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
    To investigate the spatial distribution of [11C]SMW139 specific binding in (early) AD and age/sex-matched cognitively unimpaired subjects.
    E.2.2Secondary objectives of the trial
    Secondary objectives include associations of regional [11C]SMW139 uptake with cognitive measures and measures of neurodegeneration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1: subjects along the AD continuum
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. Be along the AD continuum, defined as having positive biomarker evidence (CSF or PET) for the presence of Aβ pathology.
    2. At least 50 years of age;
    3. Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate study procedures and be competent to make a well-informed decision to participate in this study;
    4. Signed informed consent for Amsterdam Dementia Cohort (2016.061);

    Group 2: cognitively unimpaired subjects
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1. Have biomarker evidence (CSF or PET) for the absence of Aβ pathology;
    2. Have no objective cognitive impairment as determined by a neuropsychologist or neuropsychological testing;
    3. At least 50 years of age;
    4. Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate study procedures and be competent to make a well-informed decision to participate in this study.
    5. Signed informed consent for Amsterdam Dementia Cohort (2016.061);
    E.4Principal exclusion criteria
    1. Has contra indications for MRI scanning and therefore cannot receive a brain MRI;
    2. Has evidence of (gross) structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan;
    3. Inability to undergo PET-CT with administration of radioligand [11C]SMW139;
    4. Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must not be pregnant or breast feeding at screening and at imaging;
    5. Has a relevant history of severe drug allergy or hypersensitivity. This includes (but is not limited to) hay fever, allergies to cats and dogs, and dust mite allergy. Other relevant severe drug allergies or hypersensitivities should be evaluated by the Principal Investigator;
    6. Has ever participated in an experimental study with a tau, amyloid or neuroinflammation targeting agent, unless it can be documented that the subject received only placebo during the course of the trial;
    7. History of any clinically significant cardiovascular, endocrinology, hematologic, hepatobiliary, immunologic, inflammatory, metabolic, urologic, pulmonary (including asthma), neurologic (with the exception of AD), psychiatric, renal or other major disease, as determined by the principal investigator;
    8. In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/dL;
    9. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv;
    10. Has a history of severe traumatic brain injury (TBI);
    11. The following medications during the study and 4 weeks prior to [11C]SMW139 PET:
    a. Use of anticonvulsant medications;
    b. Anti-inflammatory medications (e.g. chronic NSAID use);
    c. Other medications that, in the opinion of the investigator, may interfere with the study.
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative assessment of [11C]SMW139 uptake
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all participants have completed the PET scanning.
    E.5.2Secondary end point(s)
    Neuropsychological functioning and neurodegeneration
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all participants have completed their study visits.
    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 Yes
    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
    Pathophysiology
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 Decision2023-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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