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    Summary
    EudraCT Number:2009-013030-25
    Sponsor's Protocol Code Number:GE-067-007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-013030-25
    A.3Full title of the trial
    A PRINCIPAL OPEN-LABEL STUDY TO COMPARE THE BRAIN UPTAKE OF [18F]FLUTEMETAMOL WITH BRAIN FIBRILLAR AB LEVELS DETERMINED POST-MORTEM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Autopsy brain protein study
    A.3.2Name or abbreviated title of the trial where available
    GE-067-007 Brain Amyloid Study
    A.4.1Sponsor's protocol code numberGE-067-007
    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 SponsorGE Healthcare Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGE Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare
    B.5.2Functional name of contact pointRegGEHealthcare@ge.com
    B.5.3 Address:
    B.5.3.1Street AddressThe Grove Centre, White Lion Road
    B.5.3.2Town/ cityAmersham, Buckinghamshire
    B.5.3.3Post codeHP7 9LL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailRegGEHealthcare@ge.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 nameFlutemetamol (18F) Injection
    D.3.2Product code AH110690 (18F) Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]flutemetamol
    D.3.9.1CAS number 765922-62-1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number185 to 370
    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
    GE-067-007 will determine the level of association between brain uptake of [18F]flutemetamol and brain amyloid levels. Assessments will be based on analysis of PET images and the quantitative immunohistochemical estimates of levels of amyloid as determined from post-mortem analysis of corresponding brain tissue samples.
    E.1.1.1Medical condition in easily understood language
    Possible brain protein deposits
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLGT
    E.1.2Classification code 10057167
    E.1.2Term Mental impairment disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 of blinded visual interpretations of [18F]flutemetamol PET images without anatomic brain images for detecting brain fibrillar Aβ assessed pathologically post-mortem.
    E.2.2Secondary objectives of the trial
    (1) To determine the specificity of the visual interpretations of [18F]flutemetamol PET images without anatomic brain images.
    (2) To determine the sensitivity and specificity of blinded visual interpretations of [18F]flutemetamol PET images with CT anatomic brain images, for detecting brain fibrillar Aβ assessed pathologically post-mortem.
    (3) To determine the level of association between global and regional estimates of brain uptake (SUVR) of [18F]flutemetamol and corresponding estimates of brain fibrillar Aβ levels made post-mortem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
    (2) The subject is 55 years of age or older and has been diagnosed with a terminal illness.
    (3) Informed consent has been signed and dated by the subject and/or the subject’s legally acceptable
    representative if applicable, in accordance with local regulations.
    (4) The subject has a caregiver who is reliable and will ensure that the subject complies with the protocol, if
    necessary in the judgment of the Investigator.
    (5) The subject’s general health is adequate to undergo the study procedures.
    (6) For women who are either surgically sterile (have had a documented bilateral oophorectomy and/or
    documented hysterectomy) or are postmenopausal (cessation of menses for more than 2 years), enrollment
    in the study without a pregnancy test at screening is allowed. For women of childbearing potential, the
    results of a serum and urine human chorionic gonadotropin pregnancy test (with the result known on the
    day of and before the Flutemetamol F 18 Injection administration) must be negative.
    (7) The subject is able to tolerate undergoing diagnostic quality anatomic brain imaging (usually CT).
    E.4Principal exclusion criteria
    (1)The subject has known or suspected structural brain abnormalities, such as infarcts or tumors, which may interfere with the interpretation of PET images.
    (2)The subject has a contraindication for PET.
    (3)The subject is pregnant or lactating.
    (4)The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
    (5)The subject is unable to tolerate or cooperate with study procedures.
    (6)The subject has participated in any clinical study using an investigational agent within 30 days of signing consent.
    E.5 End points
    E.5.1Primary end point(s)
    The blinded visual assessment of each subject’s Flutemetamol F 18 Injection brain PET images as normal or abnormal without anatomic brain images for reference will be performed by 5 independent blinded readers trained in the evaluation of PET fibrillar Aβ imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PET image within 35 days after screening. For patients who die during the study histopathology data will be available following post mortem examination and histopathology assessments.
    E.5.2Secondary end point(s)
    For specificity, the endpoint will be the same as the primary endpoint. For the other secondary objectives, the global and region-specific SUVR values will be the endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PET image within 35 days after screening. For patients who die during the study histopathology data will be available following post mortem examination and histopathology assessments.
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    United States
    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
    An IDMC will review the pathological data on an ongoing basis during the study and when the study has accrued a minimum of 31 brains defined as abnormal for fibrillar Aβ which each have evaluable PET images, the IDMC will declare the study complete and the study will be terminated.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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)
    Continued provision of the intervention is not applicable as the imaging agent is for diagnostic purposes to obtain quantitative measurements and there is no direct benefit to the patient.

    Participants will continue to receive the normal standards of care prior to, during and after the trial is complete.
    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 Decision2010-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-23
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