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    Summary
    EudraCT Number:2011-006195-39
    Sponsor's Protocol Code Number:EarlyAD-PET
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-19
    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 number2011-006195-39
    A.3Full title of the trial
    An open-label study to compare the prognostic value of (18F)Flutemetamol PET-imaging with longitudinal biomarker data in healthy volunteers and patients with mild cognitive impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can PET-imaging of the brain with a new compound ((18F)Flutemetamol) in healthy or mildly cognitively impaired people reveal who will develop Alzheimer's disease?
    A.4.1Sponsor's protocol code numberEarlyAD-PET
    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 SponsorSkånes universitetssjukhus
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationSkånes universitetssjukhus
    B.5.2Functional name of contact pointMinneskliniken
    B.5.3 Address:
    B.5.3.1Street AddressSimrisbanvägen 14
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code20502
    B.5.3.4CountrySweden
    B.5.4Telephone number4640335036
    B.5.5Fax number4640334604
    B.5.6E-mailoskar.hansson@med.lu.se
    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)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    Dementia and cognitive impairment; in particular mild cognitive impairment and Alzheimer's disease
    E.1.1.1Medical condition in easily understood language
    Dementia or cognitive impairment; i.e. diseases that typically cause memory problems that the patient and/or relatives have noticed.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066571
    E.1.2Term Progression of Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    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 examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD.
    E.2.2Secondary objectives of the trial
    To study whether raised [18F]Flutemetamol brain uptake is associated with other markers associated with prodromal AD, such as hippocampal atrophy, episodic memory dysfunction and cerebrospinal fluid biomarkers in patients with MCI.

    To specifically examine whether raised [18F]Flutemetamol brain uptake is associated with changes of monomeric and oligomeric forms of β-amyloid in cerebrospinal fluid.

    To study the frequency of raised [18F]Flutemetamol brain uptake in cognitively healthy elderly individuals, with no signs of early AD.
    To determine whether cognitively healthy elderly individuals with raised [18F]Flutemetamol brain uptake will develop AD in the future.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy elderly subjects (Nomas study)
    - No cognitive symptoms reported by study participant
    - Normal performance on cognitive tests
    - General cognition and functional performance preserved such that a diagnosis of MCI or dementia cannot be made by physician at the time of the baseline visit
    - Between 60 and 90 years of age
    - Fluent in Swedish
    - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.

    Mild cognitive impairment (TiDiS study)
    - Cognitive symptoms reported by patient and/or informant
    - Between 60 and 80 years of age
    - Mini-Mental State Exam score between 24 and 30
    - General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by physician at the time of the baseline visit
    - Fluent in Swedish
    - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
    E.4Principal exclusion criteria
    Exclusion Criteria (for both MCI and healthy elderly):
    - Major depression as described in DSM-IV.
    - History of schizophrenia or other recurrent psychotic disorder
    - History of alcohol or substance abuse or dependence within the past 5 years
    - Diseases that will make study participation difficult, such as terminal cancer or significant heart failure.
    - Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
    E.5 End points
    E.5.1Primary end point(s)
    Visual Detection of Raised [18F] Flutemetamol Uptake in patients with mild cognitive impairment (MCI) or healthy volunteers (HV)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after dosing
    E.5.2Secondary end point(s)
    [18F] Flutemetamol brain:cerebellar uptake ratios measured with a priori VOI analysis in subjects with MCI compared to HV.

    Associations of [18F]Flutemetamol brain uptake rations measured by VOI analysis with other diagnostic methods, including CSF biomarkers, cognitive tests and MRI findings.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after dosing
    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 No
    E.6.5Efficacy No
    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 Information not present in EudraCT
    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.8.5The 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
    This trial ends with the last visit of the last subject/patient. The participants to this study are recruited from two on-going studies that will continue.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 400
    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 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 state500
    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)
    Included subjects will be followed clinically over at least four years to determine if any of them will subsequently develop a certain dementia disorder (e.g. Alzheimer's disease). All patients that develop a dementia disorder will be taken care of by the dementa disorder clinic.
    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 Decision2012-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-30
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