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    Summary
    EudraCT Number:2011-006042-32
    Sponsor's Protocol Code Number:GE-067-019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-25
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-006042-32
    A.3Full title of the trial
    A Single-Arm Open-Label Multi-Center Study to Determine the Test-Retest Variability of PET Brain Imaging with Flutemetamol (18F) Injection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Determine the Test-Retest Variability of PET Brain Imaging with Flutemetamol (18F) Injection.
    A.3.2Name or abbreviated title of the trial where available
    Flutemetamol test - retest
    A.4.1Sponsor's protocol code numberGE-067-019
    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 and its affiliates
    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 Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressVendeväg 89 , P.O. Box 366
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code18282
    B.5.3.4CountrySweden
    B.5.4Telephone number46855959486
    B.5.5Fax numberNANANANA
    B.5.6E-mailheide.wahlen@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, radioactive
    D.3.9.1CAS number 765922-62-1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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
    Subjects with amnestic Mild Cognitive Impairment (aMCI)
    E.1.1.1Medical condition in easily understood language
    Persons with mild memory problems
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 evaluate the mean intra-subject test-retest variability in the cortical brain uptake (Standard Uptake Value Ratio (SUVR)) of [18F]flutemetamol based on a 30-minute time frame in subjects with amnestic Mild Cognitive Impairment (aMCI).
    E.2.2Secondary objectives of the trial
    (1) To evaluate the mean intra-subject test-retest variability in the cortical brain uptake (SUVR) of [18F]flutemetamol in aMCI subgroups with normal and raised tracer uptake.
    (2) To evaluate the intra-subject test-retest variability in the cortical brain uptake (SUVR) of [18F]flutemetamol as a function of the amount of uptake.
    (3) To investigate the test-retest comparison with shorter time frames (5, 10, and 20 min).
    (4) To determine the extent of agreement of the separate blinded visual assessments of a subject’s test and retest images as normal or abnormal.
    (5) To assess the safety of repeat administrations of Flutemetamol (18F) Injection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) The subject has at least a sixth grade education or has a good work history (sufficient to exclude mental retardation).
    (2) The subject’s general health is adequate to comply with study procedures, as ascertained by review of their screening medical history and physical examination.
    (3) 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 will be 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 tracer administration) must be negative.
    (4) The subject and/or the subject’s legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.
    (5) The subject is 55 years old or older.
    (6) The subject meets the Petersen criteria for aMCI.
    (7) The subject has a score of ≤ 4 on the Modified Hachinski Ischemic Scale.
    (8) The subject has a MMSE score of 24-30 (exceptions may be made for subjects with less than 8 years of education at the discretion of the Investigator).
    (9) The subject has adequate visual and auditory acuity to allow neuropsychological testing.
    (10) The subject has a non-contrast MRI examination as part of the screening visit or within the previous 6 months, that excludes aMCI arising from structural causes (e.g. vascular disease, hydrocephalus) and is of sufficient diagnostic quality (details provided in Imaging Manual) for VOI definition.
    (11) The subject is willing and able to participate in the trial.
    (12) The subject has a Hamilton Depression Scale Score of ≤ 12 on the HAM-D 17.
    E.4Principal exclusion criteria
    (1) The subject has participated in any other clinical study utilizing an investigational agent within 30 days of study entry.
    (2) The subject is pregnant or lactating.
    (3) The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
    (4) The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
    (5) The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments, or pacemakers that would pose a risk during an MRI.
    (6) The subject has major depression, bipolar disorder, as described in the DSM-IV within the past 1 year.
    (7) The subject has history of schizophrenia (DSM-IV criteria).
    (8) The subject has had, within the prior 3 months, psychotic features, agitation, or behavioral problems that could lead to protocol compliance issues.
    (9) The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
    (10) The subject has clinically significant abnormalities in serum B12, folate, or thyroid functions that might interfere with the study. High concentrations of B12 and folate will be acceptable when due to treatment.
    (11) The subject regularly took medication with known anticholinergic effects (which could impair memory) within the last 3 months or in the view of the Investigator the subject is taking a drug that could impair cognition.
    a. Patients on psychoactive medications e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics are excluded. Note: subjects may take stable doses of antidepressants lacking anticholinergic side effects, if they are not currently depressed and have not had a history of a major depressive episode within the past 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the brain uptake of [18F]flutemetamol (Standard Uptake Value Ratio (SUVR)) measured by Volume of Interest (VOI) analysis on a 30-minute scanning time.

    The primary safety endpoints Vital signs, laboratory assessments, electrocardiogram, physical/neurological examination, and AEs will be monitored and evaluated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PET imaging will be conducted for 30 minutes starting approximately 90 minutes after dosing
    E.5.2Secondary end point(s)
    The secondary endpoint will be the brain uptake of [18F]flutemetamol (SUVR) measured by VOI analysis based on 5-, 10-, and 20-minute scanning times. Also a secondary endpoint will be the blinded visual assessment of each subject’s Flutemetamol F 18 Injection brain PET images as normal or abnormal. The assessment will be performed by 5 independent blinded readers trained in the evaluation of PET fibrillar amyloid β imaging.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint will be measured by VOI analysis based on 5-, 10-, and 20-minute scanning times.
    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 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.8.3 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 concerned3
    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
    Following AE Safety follow-up call - 24 hours after second PET imaging.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    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)
    The patient is expected to continue the normal treatment of the condition.
    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 Decision2012-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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