Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-010227-62
    Sponsor's Protocol Code Number:GE-067-005
    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:2009-07-06
    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 number2009-010227-62
    A.3Full title of the trial
    A Principal Open-label Study to Assess the Prognostic Usefulness of Flutemetamol (F18) Injection for Identifying Subjects with Amnestic Mild Cognitive Impairment who will Convert to Probable Alzheimer’s Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dementia study
    A.4.1Sponsor's protocol code numberGE-067-005
    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
    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/ cityAmsersham, 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.3.9.2Current sponsor code[18F]AH110690
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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-067-005 will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer for predicting the conversion from amnestic Mild Cognitive Impairment to probable Alzheimer’s disease. Uptake assessments will be based on the visual and quantitative evaluation of Flutemetamol (18F) Injection PET scans. Quantitative evaluations will be performed separately and the independent readers will be blinded to this result.
    E.1.1.1Medical condition in easily understood language
    Dementia
    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 14.1
    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 compare the time to conversion to probable Alzheimer’s Disease (AD) in amnestic Mild Cognitive Impairment (aMCI) subjects with normal and abnormal patterns of [18F]flutemetamol uptake based on the visual assessment of a Positron Emission Tomography (PET) scan by independent, blinded readers.
    E.2.2Secondary objectives of the trial
    •To compare the proportions of normal and abnormal subjects who convert to probable AD within the follow-up period.
    •To compare the time to conversion to probable AD in aMCI subjects with [18F]flutemetamol uptake below and above a pre-defined threshold based on quantitative assessment of a Flutemetamol (18F) Injection PET scan.
    •To determine the sensitivity and specificity of the ability of [18F]flutemetamol uptake to predict eventual conversion to probable AD based on clinical testing in the time period of the study conduct. Separate determinations will be made for blinded visual image assessments and the categorisation of quantitative image assessments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The enrollment of subjects from racial/ethic minority populations is strongly encouraged.

    Subjects may be included in the study if they meet all of the following criteria:

    (1) The subject has at least a six 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 IMP 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 Petersen criteria for amnestic MCI including:
    a. The subject must have a memory complaint or a study partner that can verify a memory complaint
    b. Abnormal memory function using the scoring on the Logical Memory II
    subscale revised (delayed paragraph recall) from the Wechsler Memory scale-Revised.
    i. Less than or equal to 11 for 16 or more years of education
    ii. Less than or equal to 9 for 8-15 years of education
    iii. Less than or equal to 6 for 0-7 years of education
    c. CDR global rating of 0.5
    d. General cognition and functional ADL performance sufficiently preserved such
    that the diagnosis of possible or probable AD by NINCDS-ADRDA criteria
    cannot be made at screening
    e. An informant is available who has frequent contact with the subject and can
    accompany the subject to all clinic visits or be available to talk on the telephone
    about the subject’s memory.
    (7) The subject has a score of less than or equal to 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 Invesigator).
    (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 MCI arising from structural causes (e.g. vascular disease, hydrocephalus) and is of sufficient diagnostic quality (details provided in Imaging Manual) for Volume of Interest (VOI) definition.
    (11) The subject is willing and able to participate for at least 3 years.
    (12) The subject has a Hamilton Depression Scale Score of less than or equal to 12 on the HAM-D 17.
    E.4Principal exclusion criteria
    Subjects must be excluded from participating in this study if they meet any of the following 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
    behavioural 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 significant abnormalities in serum B12, folate or thyroid functions that might interfere with the study.
    (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, neuro- leptics, 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 endpoint is the time to conversion to probable AD of aMCI subjects with normal and abnormal patterns of [18F]flutemetamol uptake based on the independent, blinded visual assessment of a PET scan: Time 0 is the date of PET imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each subject will be assessed by the site every 6 months until they convert to AD, or, if they do not convert, until either 3 years has elapsed from imaging or the required number of conversions is reached (whichever occurs later). Once a subject converts, he/she will have reached the endpoint of the trial and no further follow-up wll be conducted for that subject.
    E.5.2Secondary end point(s)
    See objectives.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each subject will be assessed by the site every 6 months until they convert to AD, or, if they do not convert, until either 3 years has elapsed from imaging or the required number of conversions is reached (whichever occurs later). Once a subject converts, he/she will have reached the endpoint of the trial and no further follow-up wll be conducted for that subject.
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1.1In 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 230
    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)
    See protocol
    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 Decision2009-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-16
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 01:24:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA