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    Summary
    EudraCT Number:2017-002527-21
    Sponsor's Protocol Code Number:AMYPAD-01
    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:2018-03-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002527-21
    A.3Full title of the trial
    Multicentre, Open-label, Randomised Study to Assess the Diagnostic Value of Amyloid PET Imaging in Patients with Subjective Cognitive Decline Plus, Mild Cognitive Impairment, or Dementia Where Alzheimer’s Disease is in the Differential Diagnosis
    Multi-centrum, open-label, gerandomiseerde studie voor het vaststellen van de diagnostische waarde van Amyloid PET in patienten met subjectieve klachten, milde cognitieve achteruitgang of dementie met de ziekte van Alzheimer in de differentiaal diagnose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic and Patient Management Study
    Diagnostische en Patient Management Studie
    A.3.2Name or abbreviated title of the trial where available
    DPMS
    A.4.1Sponsor's protocol code numberAMYPAD-01
    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 Geneva
    B.1.3.4CountrySwitzerland
    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 supportInnovative Medicines Initiative 2 Joint Undertaking
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEFPIA (from Janssen Pharmaceutical)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEFPIA (from Piramal Imaging)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportEFPIA (from GE Healthcare)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSECRETARIAT D'ETAT A LA FORMATION A LA RECHERCHE ET A L'INNOVATION (SEFRI)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Geneva
    B.5.2Functional name of contact pointLANVIE
    B.5.3 Address:
    B.5.3.1Street AddressChemin du Petit-Bel-Air 2
    B.5.3.2Town/ cityChêne Bourg
    B.5.3.3Post code1225
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00412230 54758
    B.5.6E-mailgiovanni.frisoni@gmail.com
    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
    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.IMP: 2
    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 Vizamyl
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare 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.3.4Pharmaceutical form Solution for injection
    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
    Alzheimer's disease
    Mild Cognitive Impairment
    Subjective Cognitive Decline Plus
    Ziekte van Alzheimer
    Mild cognitieve achteruitgang
    Subjectieve cognitieve klachten
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s disease (AD) is a progressive disorder and it is the most common cause of cognitive impairment and dementia.
    De ziekte van Alzheimer is de meest voorkomende oorzaak van cognitieve achteruitgang en dementie.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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 test the hypothesis that the proportion of subjects for whom the managing physician reaches an aetiologic diagnosis with very high confidence (≥90%) at 12 weeks after baseline is higher for subjects who underwent amyloid PET imaging shortly after baseline than for subjects who have not yet undergone amyloid PET imaging (ie, subjects scheduled to undergo amyloid PET imaging at 8 months [±8 weeks] after baseline).
    E.2.2Secondary objectives of the trial
    1) To assess the impact of amyloid PET imaging on Diagnosis and confidence (Time to communicate to the patient an aetiologic diagnosis with very high confidence (≥90%); Changes in the managing physician’s aetiologic diagnosis and diagnostic confidence over time; and the managing physician’s estimate of the likelihood that the patient’s symptoms are due to AD.
    2) To assess the impact of amyloid PET imaging on diagnostic and patient management, including: change or early adoption of programs and pharmacologic treatments aimed to delay the onset or progression of cognitive impairment; and Use of medical resources.
    3) To assess the impact of amyloid PET imaging on:
    • Patient-related outcomes (cognition, anxiety, depression, coping skills, and quality of life)
    • Cost of diagnostic workup to the aetiologic diagnosis with very high confidence (≥90%)
    • Number of patients who are discharged from the memory centre and the reason for discharge
    4) Imaging results assessment

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study title: Disclosure of amyloid PET results to persons with subjective cognitive decline - A spontaneous AMYPAD sub-study
    Version: 1.0, July 2018

    Objective: Aim of this study is to survey the communication practices of memory clinics to patients with SCD undergoing amyloid PET for risk profiling, and patient outcomes.
    E.3Principal inclusion criteria
    • The patient can be male or female and of any race or ethnicity.
    • The patient must be 60 to 85 years of age (for patients with SCD-Plus) or 50 to 85 years of age (for patients with MCI or with dementia where AD is in the differential diagnosis).
    • The patient must have a complaint (reported by the patient or by a caregiver) of cognitive problems that are considered by the managing physician to be possibly due to AD.
    o The patient must be entering a diagnostic assessment for the cognitive complaint.
    o The patient’s managing physician at the memory clinic must feel that knowledge of the patient’s brain amyloid status may increase diagnostic confidence and alter diagnosis and management.
    o Patients should not have known amyloid status prior to randomization.
    • The patient must satisfy the diagnostic criteria for one of the following:
    o SCD-Plus
    o MCI
    o Dementia, where AD is in the differential diagnosis
    • The patient has an MRI and/or CT scan that excludes an intracranial mass or other lesion(s) that could explain cognitive impairment.
    • The patient can complete all clinical visits according to the protocol.
    • The patient can tolerate a 20-minute amyloid PET scan.
    • The patient provides informed consent for study participation and data source verification.
    • If the patient has dementia, he or she has a study partner willing and able to accompany him or her to all visits for the duration of the protocol
    E.4Principal exclusion criteria
    Subjects must be excluded from participating in this study if they meet any of the following criteria:
    • The patient has another confirmed condition that can fully account for the cognitive impairment, including but not limited to psychiatric disorders (schizophrenia, mood disorders, bipolar disorder and personality disorders; neuroinflammatory, neuroinfective, or neurodegenerative diseases; multiple sclerosis; genetic disorders; HIV; brain injuries; neurosurgery aftereffects; major depressive episode; schizoaffective disorder; delusional disorder; delirium). Patients with long-known, stabilized psychiatric or other brain conditions that cannot fully account for the cognitive impairment may be included in the study.
    • The patient came to observation of the memory clinic for reasons other than diagnosis (disability assessment for social aids, cognitive assessment for driving license, etc.)
    • The patient had a previous beta-amyloid imaging scan and/or has had other diagnostic workup (fluorodeoxyglucose [FDG]-PET and/or cerebrospinal fluid [CSF] analysis) for a cognitive complaint prior to the screening. (In some centres, the patient may receive a diagnostic workup before the screening for this study. These patients can be enrolled in the study only if the investigator is blinded to the results of those tests until after randomization.
    • The patient has any life-threatening unstable medical disease or psychiatric condition that could lead to difficulty in complying with the protocol.
    • The patient is currently receiving an investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening, and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
    • The patient is a woman who is pregnant, planning to become pregnant, or lactating. Pregnancy status of a woman with childbearing potential will be carried outchecked before the PET scan. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (www.hma.eu/ctfg.html, Recommendations related to contraception and pregnancy testing in clinical trials, September 2014).
    • The patient is employed at the research department or memory clinic, is directly involved with the study, or is not a family relative from any department personnel (i.e. partner, older child, sibling, biological or legal representative).
    • Any of the contraindications as registered for the study drug used is applicable to the subject. Any of the warnings or precautions as registered for the IMP used is applicable to the subject, unless a risk-benefit assessment is favorable as per the judgement of the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    The difference, at 12 weeks after baseline, between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in the proportion of patients for whom the managing physician has made an aetiologic diagnosis with very high confidence (≥90%). Diagnostic confidence, which is the managing physician’s confidence that the diagnosis is correct, will be measured with a visual analogue scale (VAS) from 0% (no confidence) to 100% (full confidence).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 weeks after Baseline
    E.5.2Secondary end point(s)
    Diagnosis and Confidence
    • The difference between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in the time (from baseline) to communicate to the patient an aetiologic diagnosis with very high confidence (≥90%).
    • Change of etiologic diagnosis and incremental diagnostic confidence between Baseline visit (T0) and T1 in each arm.
    • ‘The changes in the managing physician’s aetiologic diagnosis at T3 vs T2 vs T1 in each arm.
    • The changes in the managing physician’s diagnostic confidence at T3 vs T2 vs T1 vs T0 in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm.
    • The managing physician’s estimate of the likelihood that the patient’s symptoms are due to AD at T3 vs T2 vs T1 vs T0 in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm.
    • Changes over calendar time in the placement of amyloid PET imaging in the patient workup for subjects in the Free Choice Amyloid PET Imaging arm.

    Patient Management
    • The difference between arms (Early Amyloid PET Imaging arm, the Late Amyloid PET Imaging arm, or the Free Choice Amyloid PET Imaging arm) in the number of patients randomised to disease-modifying drug (DMD) or any other AD clinical trial at T2.
    • The difference between the Early Amyloid PET Imaging arm and the Late Amyloid PET Imaging arm in number of subjects with changes in the management plan (changes in or start of a new program or pharmacologic treatment) at T1 vs T2 vs T3.

    • Health Economics and Outcomes Research (HEOR) The impact on patient-related outcomes (cognition, anxiety, depression, coping skills, and quality of life) at T3 vs T2 vs T0 in each arm
    • The difference in the cost of diagnostic workup to the aetiologic diagnosis with very high confidence (≥90%) in the Early Amyloid PET Imaging arm vs the Late Amyloid PET Imaging arm. (In those centres where the subjects in the Early Amyloid PET Imaging arm receive a diagnostic workup in addition to clinical evaluation before baseline, the relative costs will not be considered if the results of those exams are not known by the managing physician before the managing physician makes the aetiologic diagnosis.)
    • Differences in the use of medical resources (not limited to diagnostic procedures, tests, visits, and hospitalisations) and programs between Early Amyloid PET Imaging and Late Amyloid PET Imaging arms.
    • The number of patients who withdraw from the study and the reasons for withdrawal.

    Imaging Results Assessment
    • Descriptive analysis of local visual assessment results
    • Mean values of quantitative image assessments (composite cortical standardised uptake value ratios [SUVR] and converted to the centiloid scale) across amyloid PET tracers and by diagnostic subgroup.
    • The composite cortical quantitative uptake (SUVR and SUVR converted to the centiloid scale) vs visual reading interpretation
    • For each of the amyloid PET tracers, the differences in regional quantitative uptake between diagnostic strata.

    For subjects in the Early Amyloid PET Imaging arm who have a second amyloid PET scan:
    • The longitudinal development of quantitative image assessments (regional and composite cortical SUVR and SUVR converted to the centiloid scale)
    • The difference in amyloid load, as indicated by quantitative image assessments, between the first and the second amyloid PET scan
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints are defined as follows: T0 = baseline, T1 = 12 weeks after T0, T2 = 6 months (±14 days) after T0, T3 (optional) = 13 months (±4 weeks) after T0; T4 (optional) = ≤28 days after the second scan, which will be approximately 18 months after T0. (All time points are calculated relative to baseline.)
    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 Yes
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months60
    E.8.9.2In all countries concerned by the trial days0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    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 state112
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 784
    F.4.2.2In the whole clinical trial 900
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Stichting VUmc
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation The University of Edinburgh
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Barcelonabeta Brain Research Center
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Karolinska Institutet
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Centre Hospitalier Universitaire de Toulouse
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation University College London
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation University Hospital of Cologne
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Stichting Katholieke Universiteit
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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