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    Summary
    EudraCT Number:2010-023852-10
    Sponsor's Protocol Code Number:18F-AV-45-020
    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:2011-08-01
    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 number2010-023852-10
    A.3Full title of the trial
    18F-AV-45 Amyloid PET Imaging in Primary Progressive Aphasia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    None
    A.3.2Name or abbreviated title of the trial where available
    Florbetapir Amyloid PET Imaging in Focal Dementia Syndromes
    A.4.1Sponsor's protocol code number18F-AV-45-020
    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 SponsorAvid Radiopharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportAvid Radiopharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkos, Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressThe Coach House, The Grove, Pipers Grove
    B.5.3.2Town/ cityHarpenden, Hertfordshire
    B.5.3.3Post codeAL5 1AH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+ 441 582736339
    B.5.5Fax number+ 441 582764327
    B.5.6E-mailratakos@akos.co.uk
    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 nameFlorbetapir 18F Solution for Injection
    D.3.2Product code 18F-AV-45
    D.3.4Pharmaceutical form 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 INNFlorbetapir (18F)
    D.3.9.1CAS number 956103-76-7
    D.3.9.2Current sponsor code18F-AV-45
    D.3.9.3Other descriptive nameFlorbetapir F 18 Injection, AMYViD® Injection
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number54
    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
    Focal dementia syndromes - primary aphasia
    E.1.1.1Medical condition in easily understood language
    Gain better understanding of the causes of different types of speech and other symptoms found in different forms of dementia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012292
    E.1.2Term Dementia of the Alzheimer's type NOS
    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
    Use florbetapir 18F PET imaging to investigate the pathological underpinning of the neuropsychologically distinct variants of progressive aphasia and compare these patterns of florbetapir 18F uptake with "typical" Alzheimer's disease and age-matched controls
    E.2.2Secondary objectives of the trial
    To investigate associations between focal brain atrophy, cortical thickness and regional amyloid uptake in amyloid positive variants of these syndromes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PPA Group
    1. Are currently enrolled in the longitudinal study of frontotemporal lobular degeneration at the Dementia Research Centre (DRC) at UCL
    2. Patients with PPA will have undergone detailed neuropsychological assessments and will be classified in one of three syndromic groups:PNFA, LPA, or SD
    3. Can tolerate a PET scan procedure

    PCA-AD Group
    1. Are currently enrolled in the longitudinal study of frontotemporal lobular degeneration at the Dementia Research Centre (DRC)
    2. Patients with PCA-AD will have undergone detailed neurological assessments and will fulfil the following criteria: 1) insidious onset of cognitive decline, sufficient to interfere with activities of daily living, with absence of structural lesion or significant whilte matter disease on MRI. 2) relatively preserved episodic memory; deficits on standard psychological testing in at least two of four posterior cortical functions: (a) object perception (b) space perception (c) calculation (d) spelling
    3. can tolerate a PET scan procedure

    Cognitively normal group
    1. have no cognition complaints
    2. are between 55 and 90 years of age
    3. give informed consent
    4. can tolerate a PET scan procedure
    E.4Principal exclusion criteria
    1. Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
    2. Have a clinically significant cardiovascular disease
    3. Have a clinically significant infectious disease
    4. Have a history of alcohol or substance abuse or dependence
    5. Have a history of severe drug allergy or hypersensitivity
    6. Women of child bearing potential
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative and qualitative assessments of florbetapir 18F uptake to test the primary hypotheses
    E.5.1.1Timepoint(s) of evaluation of this end point
    Complete imaging of all subjects
    E.5.2Secondary end point(s)
    Descriptive assessment of the focality and asymmetry of amyloid uptake and glucose hypometabolism between various groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    Complete imaging of all subjects
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number 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 concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alzheimer's disease, FTLD
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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)
    Each subject will be contacted by phone 1-3 days after dosing to determine the subject's well being and record any potential adverse events post dose
    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 Decision2011-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-08
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