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    Summary
    EudraCT Number:2018-003473-94
    Sponsor's Protocol Code Number:UCL-2016-121
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-03-28
    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 number2018-003473-94
    A.3Full title of the trial
    Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms.
    Imagerie des protéines tau et amyloide dans le vieillissement normal, la maladie d'Alzheimer débutante, et les syndromes apparentés.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms.
    Imagerie des protéines tau et amyloide dans le vieillissement normal, la maladie d'Alzheimer débutante, et les syndromes apparentés.
    A.4.1Sponsor's protocol code numberUCL-2016-121
    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 SponsorCliniques Universitaires Saint-Luc
    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 supportFNRS
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint-Luc
    B.5.2Functional name of contact pointFloriane Adriaens
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate 10
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227648540
    B.5.6E-mailguichetacademique@saintluc.uclouvain.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 nameF18-MK6240
    D.3.4Pharmaceutical form Solution for injection/infusion
    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
    Alzheimer’s disease (AD)
    E.1.1.1Medical condition in easily understood language
    Alzheimer is defined pathologically by the presence of tau tangles and amyloid senile plaques in the neocortex. To quantify pTAU in vivo, p-tau PET tracers have now been developed, like F18-MK6240.
    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
    Evaluate the regional deposition of p-TAU protein aggregates using F18-MK6240 PET/CT, non-invasive in vivo imaging within the brain of patients affected by several neurodegenerative disorders. Patients’ data (MCI, mild AD, non-AD dementia) will be compared to a control group data.
    Specific aims: To evaluate how:
    1)tau PET signal distinguish patients with AD, patients with non-AD syndrome, and controls
    2)tau PET signal depends on age, and on genetic risks in non-demented controls
    3)To compare tau PET imaging to tau measures in the cerebrospinal fluid (CSF)
    4)tau PET imaging can predict progression to dementia in MCI and control participants
    5)tau PET signals relate to (functional) MRI data
    6)tau PET signals relate to blood-derived biomarkers
    7)tau PET signals relate to cognitive performance
    8)tau PET signals relate to electroencephalographic (EEG) signals
    9)tau PET measures evolve over time, in relation to cognitive performance and the other biomarkers
    Évaluer le dépôt régional d'agrégats de protéines p-TAU à l'aide du PET/CT F18-MK6240, imagerie in vivo non invasive dans le cerveau de patients atteints de plusieurs troubles neurodégénératifs. Les données des patients seront comparées à celles d'un groupe de contrôle.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with MCI due to AD or mild AD :
    • Age at least 45 years
    • Able to read and write in French, with a minimum 5 years of formal education
    • Attended the Memory Clinic of Cliniques Universitaires Saint-Luc
    • Are able to consent and willing to participate in the study
    • Are diagnosed either with mild cognitive impairment (MMSE ≥ 24/30) using the Petersen criteria (2004) or with mild AD dementia (MMSE ≥ 20/30) using the McKhann criteria (2011) by a clinical neurologist.
    • Have a study partner or can identify someone willing in principle to be a study partner
    • Have either a positive amyloid-PET scan OR an abnormal measure of Aβ-42 in the CSF OR an abnormal ratio between total tau and Aβ-42 in the CSF.
    Patients with non-AD syndrome
    • Age at least 20 years
    • Able to read and write in French, with a minimum 5 years of formal education
    • Attended the Memory Clinic, the Stroke Clinic (CAA), the Neuromuscular Clinic (ALS), or the Movement Disorder (PSP/CBD/LBD) Clinic of Cliniques Universitaires Saint-Luc
    • Are able to consent and willing to participate in the study
    • Are clinically suspected to suffer:
    - from cerebral amyloid angiopathy (CAA), Fronto-temporal Lobar Degeneration, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy body disease, or Amyotrophic Lateral Sclerosis by a clinical neurologist.
    - from MCI due to AD or mild AD dementia but have either a negative amyloid-PET scan OR a normal measure of Aβ-42 in the CSF
    • Have a study partner or can identify someone willing in principle to be a study partner

    Non-demented controls
    • Age at least 20 years
    • Able to read and write in French; minimum 5 years of formal education
    • Recruited among caregivers of patients attending the Memory Clinics, through advertisement, or among patients attending the Memory Clinics but with normal neuropsychological exam.
    • Are able to consent and willing to participate in the study
    • Have normal cognition as defined by an MMSE ≥ 26/30 (25/30 if education lower than high school).
    • Have an available amyloid-PET scan OR an available CSF measure of Aβ-42 conducted for clinical reasons OR in another research study OR are willing to undertake an amyloid-PET scan for the present study OR are willing to undertake a CSF measure of Aβ-42 for the present study.
    E.4Principal exclusion criteria
    • Presence of any neurological, psychiatric or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including but not limited to pre-manifest Huntington’s disease, multiple sclerosis, active alcohol/drug abuse or major psychiatric disorders including current major depressive disorder, schizophrenia, schizoaffective or bipolar disorder.
    • Any cancer or history of cancer in the preceding 2 years (excluding cutaneous basal or squamous cell cancer resolved by excision and localized prostate cancer in male subjects)
    • Any current medical conditions that are clinically significant and might make the subject’s participation in an investigational trial unsafe, e.g., uncontrolled or unstable disease of any major organ system; history within the last 3 months of any acute illness of a major organ system requiring emergency care or hospitalization, including re-vascularization procedures; severe renal or hepatic failure; unstable or poorly controlled diabetes mellitus, hypertension, or heart failure; any clinically relevant abnormalities in blood parameters in routine assessments; severe loss of vision, hearing or communicative ability; or any conditions preventing co-operation or completion of the required assessments in the trial, as judged by the investigator.
    • Any contraindications for MRI or PET scan
    • Any evidence of intracranial pathology which, in the opinion of the Investigator, may affect cognition, including but not limited to brain tumors (benign or malignant), aneurysm or arteriovenous malformations, territorial stroke (excluding smaller watershed strokes), recent hemorrhage (parenchymal or subdural), or obstructive hydrocephalus. Participants with a MRI scan demonstrating markers of small vessel disease (e.g. white matter changes or lacunar infarcts) judged to be clinically insignificant, or microbleeds are allowed.
    • Participation in a clinical trial of an investigational product (IMP) in the 30 days preceding the screening visit. Entering a clinical trial of an investigational product (IMP) is allowed during the current study once the baseline examinations have been performed. The follow-up examinations scheduled in the current study will be proposed to the participants who will have entered a clinical trial during their participation in the current study, depending on the examinations that are scheduled in the clinical trial.
    • Women of child-bearing potential (WOCBP , non-menopausal), younger than 55 years old, following any method of contraception not recommended by the Clinical Trial Facilitation Group (CTFG ). The use of a highly effective contraception measure2 should indeed be maintained during any F18 radio-labelled pharmaceutical exposure, until complete F18 decay (meaning at least a minimum period of 18-24 hours after injection).
    • Pregnancy, or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    F18-MK6240 regional SUVr or spatial extension measure differences between patients and controls
    F18-MK6240 SUVr régional ou l'extension spatiale mesure les différences entre les patients et les témoins
    E.5.1.1Timepoint(s) of evaluation of this end point
    The inclusion period is scheduled to end on the 30th June 2029. Follow-up is scheduled for a ten-year period (end on 30th June 2039). The minimal follow-up will include a cognitive assessment, a blood-test and a blood pressure measurement. All imaging examinations are optional at follow-up. Examinations will globally be repeated every two years.
    La période d'inclusion devrait se terminer le 30 juin 2029. Le suivi est prévu pour une période de dix ans (fin le 30 juin 2039). Le suivi minimal comprendra une évaluation cognitive, un test sanguin et une mesure de la pression artérielle. Tous les examens d'imagerie sont facultatifs lors du suivi. Les examens seront globalement répétés tous les deux ans.
    E.5.2Secondary end point(s)
    Associations between F18-MK6240 regional SUVr or spatial extension measures and:

    Cognitive outcomes
    - Global cognitive measures (e.g., MMSE, TICS)
    - Verbal Episodic Memory (e.g., Free and Cued Selective Reminding Test, FCSRT)
    - Visuospatial/Constructional (e.g., CERAD Figures Copy)
    - Language (e.g., Picture Naming, Semantic Fluency, Letter Fluency)
    - Attention/Executive Functioning (e.g., Trail-Making-Test)
    - Spatial navigational skills;
    - Face perception and recognition abilities;
    - Specific semantic memory measures;
    - Short-term memory binding abilities;
    - Specific episodic memory processes (e.g., pattern separation, pattern completion);
    - Implicit learning abilities.
    CSF biomarker outcomes
    - Aβ, t-tau, p-tau
    Amyloid-PET imaging
    - Global and regional distribution of amyloid deposition
    Neuroimaging outcomes (MRI)
    - Regional and whole brain volume
    - Regional cortical thickness
    - Resting-state functional connectivity
    - Diffusion-weighted imaging
    - Task-related brain activity
    Blood-derived biomarkers
    - Amyloid oligomers
    - Phosphorylated and non-phosphorylated tau species
    Associations entre le SUVr régional F18-MK6240 ou les mesures d'extension spatiale et :

    Résultats cognitifs
    - Mesures cognitives globales (p. ex. MMSE, TICS)
    - Mémoire épisodique verbale (p. ex. test de rappel sélectif libre et dirigé, FCSRT)
    - Mémoire visuospatiale/constructionnelle (p. ex. CERAD Figures Copy)
    - Langage (par exemple, dénomination d'images, fluidité sémantique, fluidité verbale)
    - Attention/fonctionnement exécutif (p. ex. Trail-Making-Test)
    - Compétences en matière de navigation spatiale ;
    - Capacités de perception et de reconnaissance des visages ;
    - Mesures spécifiques de la mémoire sémantique ;
    - Capacités de liaison de la mémoire à court terme ;
    - Processus spécifiques de la mémoire épisodique (par exemple, séparation des formes, achèvement des formes) ;
    - Capacités d'apprentissage implicite.
    Résultats des biomarqueurs du LCR
    - Aβ, t-tau, p-tau
    Imagerie TEP de l'amyloïde
    - Distribution globale et régionale des dépôts amyloïdes
    Résultats de la neuro-imagerie (IRM)
    - Volume régional et total du cerveau
    - Épaisseur corticale régionale
    - Connectivité fonctionnelle à l'état de repos
    - Imagerie pondérée en diffusion
    - Activité cérébrale liée à la tâche
    Biomarqueurs dérivés du sang
    - Oligomères amyloïdes
    - Espèces tau phosphorylées et non phosphorylées
    E.5.2.1Timepoint(s) of evaluation of this end point
    The inclusion period is scheduled to end on the 30th June 2029. Follow-up is scheduled for a ten-year period (end on 30th June 2039). The minimal follow-up will include a cognitive assessment, a blood-test and a blood pressure measurement. All imaging examinations are optional at follow-up. Examinations will globally be repeated every two years.
    La période d'inclusion devrait se terminer le 30 juin 2029. Le suivi est prévu pour une période de dix ans (fin le 30 juin 2039). Le suivi minimal comprendra une évaluation cognitive, un test sanguin et une mesure de la pression artérielle. Tous les examens d'imagerie sont facultatifs lors du suivi. Les examens seront globalement répétés tous les deux ans.
    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) 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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    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 years10
    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: 150
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 350
    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 state500
    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 Decision2019-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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