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    Summary
    EudraCT Number:2009-012569-79
    Sponsor's Protocol Code Number:BAY94-9172/14595
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-27
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012569-79
    A.3Full title of the trial
    An open-label, non-randomized study to evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) imaging for detection/exclusion of cerebral ß-amyloid when compared to postmortem histopathology
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of PET imaging with BAY 94-9172 (ZK 6013443)
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy of positron emission tomography imaging with BAY 94-9172 (ZK 6013443)
    A.4.1Sponsor's protocol code numberBAY94-9172/14595
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clin. Trials Contact CTP Team
    B.5.3 Address:
    B.5.3.1Street AddressBayer Pharma AG, S102, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 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 nameFlorbetaben (BAY 94-9172)
    D.3.2Product code ([F-18]AV1/ZK)
    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 INNFlorbetaben (18 F)
    D.3.9.2Current sponsor codeBAY 94-9172
    D.3.9.3Other descriptive nameFLORBETABEN
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    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
    Detection/Exclusion of cerebral ß-amyloid.

    To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.
    E.1.1.1Medical condition in easily understood language
    Early diagnosis of AD
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.
    E.2.2Secondary objectives of the trial
    To determine the sensitivity and specificity of the composite "whole
    brain" regional visual assessment collapsed from the regional PET visual assessment results in detecting/excluding cerebral ß-amyloid plaques based on the "whole brain" histopathological verification of the presence/absence of ß-amyloid deposition.
    To determine the sensitivity and specificity of the quantitative
    assessment of regional tracer uptake in BAY 94-9172 PET images
    compared to histological verification of the presence or absence of
    cerebral ß-amyloid in the respective postmortem specimens as the
    standard of truth.
    To determine the sensitivity and specificity of the visual assessment of BAY 94-9172 PET images on the subject level (according to the RCTU and BAPL rating scale) in detecting/excluding cerebral ß-amyloid compared to the onsite neuropathological diagnosis as the standard of reference.
    To evaluate the safety and tolerability of a single dose of BAY 94-9172 (ZK 6013443).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with a low probability of cerebral ß-amyloid deposition, e.g. non-demented volunteers and subjects with a high probability of ß-amyloid deposition, e.g.patients diagnosed with AD or Dementia with Lewy Bodies (DLB), 10 cognitively normal and young healthy volunteers between 21 and 40 years of age.

    Each study participant has to meet the following criteria:

    - is at least 21 years of age
    - females, no child-bearing potential or negative urine pregnancy test on day of BAY 94-9172 injection
    - exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
    - is willing and able to lie down in MRI and PET scanners
    - is willing to donate their brain for postmortem examination in case of death (this consent can be obtained in the manner specific to the country/region involved and is not required of the 10 young healthy volunteer study participants)
    - the subject, or the subject and its legally acceptable representative (e.g., for probable AD and DLB patients), will be compliant and have a high probability of completing the study in the opinion of the investigator
    - has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (e.g., for probable AD and DLB patients)
    - the subject who has participated in a previous florbetaben study eg, study 311741, may be included in the present study. The MRI- and florbetaben PET scan do not need to be repeated if both scans were performed within twelve months prior to inclusion.

    Inclusion criteria for the additional 10 negative controls only
    - is ≥ 21 to ≤ 40 years of age
    - has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, Hughes et al, 1982) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental Status Examination (MMSE, Folstein et al, 1975)
    - has no evidence of cognitive impairment as indicated by the CERAD neuropsychological test battery based on the results of each of the subtests (except MMSE which is covered by criterion 9 above)
    - has MRI brain scan that has been judged as "normal (age-appropriate)" including ARWMC scale (Wahlund et al, 2001) scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) and a Scheltens scale (Scheltens et al, 1992) verifying the lack of cerebral atrophy (e.g., bilateral temporal lobe atrophy visual score of 0 or 1).
    E.4Principal exclusion criteria
    Each subject who meets any of the following criteria must not participate in this study:

    - has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI
    - has any contraindication to magnetic resonance imaging (MRI) examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
    - is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following study drug administration
    - is allergic to the study drug or any of its constituents
    - has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to or a therapeutic radiopharmaceutical (e.g. 131I) within 10 days prior to the administration of the study drug or for whom administration of such substances is planned within 7 days following study drug administration
    - has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to treatment and/or was administered a radiopharmaceutical within 10 radioactive half-lives to study drug administration in this study*
    - has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e., catecholamine infusion)

    *NOTE for subjects in Germany only: According to the German Radiation Protectin Law, subjects in Germany with a low probability of cerebral β-amyloid deposition in the brain are not allowed to receive more than 10 mSv of radiation within a 10 year period and therefore will undergo the initial PET scan only; the yearly follow-up PET scans are prohibited.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy variables of the study will be the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images in correctly differentiating between brain regions with and without ß-amyloid deposition.
    E.5.2Secondary end point(s)
    To determine the sensitivity and specificity of the composite “whole brain” (per subject) regional visual assessment collapsed from the regional PET visual assessment results in detecting/excluding cerebral β-amyloid plaques based on the "whole brain"
    histopathological verification of the presence/absence of β-amyloid deposition (collapsed from the results of the regional histological findings from the Pathology Consensus Panel).
    To determine the sensitivity and specificity of the quantitative assessment of regional tracer uptake in BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective postmortem specimens as the
    standard of truth.
    To determine the sensitivity and specificity of the visual assessment of BAY 94-9172 PET images on the subject level (according to the RCTU and BAPL rating scale) in detecting/excluding cerebral β-amyloid compared to the onsite neuropathological diagnosis as the standard of reference.
    To evaluate the safety and tolerability of a single dose of BAY 94-9172 (ZK 6013443).
    To perform an exploratory investigation of the association between the subject level visual assessment of BAY 94-9172 and FDG PET images for detecting the abnormalities in patients with AD compared to individuals with other types of dementia and/or without
    cognitive impairment. The on-site clinical diagnosis (if available) will serve as the reference standard.
    To investigate the association between the visual assessments of the regional tracer uptake apparent in BAY 94-9172 PET images and the regional glucose hypometabolism as seen in the FDG PET images in patients with AD compared to individuals with other types of dementia and/or without cognitive impairment.
    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 Yes
    E.6.5Efficacy Yes
    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) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    BAY94-9172: indicated for the detection of beta-amyloid in the brain compared to postmortem specimen
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Australia
    Japan
    United States
    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
    For the end of this phase 3 study, the sponsor will closely survey the number of valid cases in each group of study participants. If the maximum number of valid patients in a specified group is enrolled, the investigators will immediately be informed to no longer enroll subjects within this group.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 174
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-08-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with dementia
    Non-demented volunteers
    In dieser klinischen Prüfung sollen auch Patienten eingeschlossen die nicht einwilligungsfähig sind und unter gesetzlicher Betreuung stehen, oder nicht einwilligungsfähig sind, für die ein Angehöriger aber eine Vorsorgevollmacht hat.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 250
    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)
    No plans for treatment or care after the subject has ended his/her participation in the trial.
    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 not applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-09-18
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