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    Summary
    EudraCT Number:2008-003597-18
    Sponsor's Protocol Code Number:18F-AV-45-010
    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:2009-04-14
    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 number2008-003597-18
    A.3Full title of the trial
    A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteers
    A.4.1Sponsor's protocol code number18F-AV-45-010
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN58435532
    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 organisation
    B.5.2Functional name of contact point
    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
    D.3.2Product code 18F-AV-45
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 956103-76-7
    D.3.9.2Current sponsor code18F-AV-45
    D.3.9.3Other descriptive nameflorbetapir 18F Injection
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/µl megabecquerel(s)/microlitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Use of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061816
    E.1.2Term Diagnostic procedure
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare amyloid pathology as determined by 18F-AV-45 positron emission tomography (PET) in patients with frontal temporal dementia (FTD) vs. Alzheimer's disease (AD);
    2. To expand the database of 18-F-AV-45 PET imaging in cognitively normal volunteers;
    3. To expand the database of 18F-AV-45 PET imaging in AD and FTD patients to determine if 18F-AV-45 PET imaging yields the expected prevalence of AB positivity in clinically defined AD and FTD patients, based on historical autopsy data:
    4. To determine the relationship between 18F-AV-45 in-vivo kinetics, cortical atrophy and metabolic impairment in FTD.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be enrolled in the probable AD group if they:
    • Are at least 50 years old (male or female);
    •Subjects whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months.
    • Meet the National Institute of Neurological and Communication Disorders and Stroke (NINCDS) criteria for probable AD and have a Mimi Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
    • Have a caregiver who can report on their mental status and activities of daily living (ADL); and
    • Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).

    Patients may be enrolled in the FTD group if they;
    • Are at least 45 years old (male or female);
    • Meet the consensus criteria for FTD (Neary, Snowden et al., 2005) and have mild to moderate disease with the clinical phenotype of behavioural-disexecutive FTD;
    • Have a caregiver who can report on their mental status and ADL; and
    • Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).

    Subjects may be enrolled in the cognitively normal volunteer group if they:
    • Are at least 45 years old (male or female);
    • Have an MMSE score ≥ 29 and are cognitively normal by informant report and on the psychometric test battery at screening; and
    • Give informed consent.


    E.4Principal exclusion criteria
    • History of or current clinically significant neurological disease other then AD or FTD;
    • Previous or current diagnosis of other dementing/neurodegenerative disease (Parkinson’s disease, dementia with Lewy bodies, Lewy body variant AD etc);
    • Previous or current diagnosis of mixed dementia;
    • Evidence (eg MRI, other biomarkers) suggesting dementia other than AD or FTD (or in cognitively normal volunteers any suggestion of AD or FTD) or other neurological pathology (eg stroke, head trauma etc);
    • Current clinically significant cardiovascular disease or abnormalities on screening ECG;
    • Current clinically significant psychiatric disease;
    • Current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment or cancer;
    •Clinical significant infectious disease;
    •Recent history of alcohol or substance abuse or dependence;
    •Women of childbearing potential who are not surgically sterile or are not refraining from sexual activity while not using reliable methods of contraception;
    •Require medicines with narrow therapeutic window;
    •Previous participation in a study with amyloid targeting agent;
    •Radiopharmaceutical imaging or treatment within 7 days of the day of imaging.
    E.5 End points
    E.5.1Primary end point(s)
    evaluation of FDG PET imaging

    evaluation of amyloid imaging
    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 No
    E.6.6Pharmacokinetic Yes
    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 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 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.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    per protocol
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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 frontal temporal dementia or Alzheimer's disease may not be competent to give consent. Consent will be given by the caregiver and assent confirmed by patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    per 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 Decision2009-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-12
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