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    Summary
    EudraCT Number:2016-003440-36
    Sponsor's Protocol Code Number:I8D-MC-AZFD
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-003440-36
    A.3Full title of the trial
    A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer’s Disease Dementia (Extension of Study AZES, The AMARANTH Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of LY3314814 in early Alzheimer's disease dementia
    A.4.1Sponsor's protocol code numberI8D-MC-AZFD
    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 SponsorEli Lilly and Company Limited
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY3314814
    D.3.2Product code LY3314814
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Yet Available
    D.3.9.2Current sponsor codeLY3314814
    D.3.9.3Other descriptive nameLY3314814
    D.3.9.4EV Substance CodeSUB181816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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.IMP: 2
    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 nameLY3314814
    D.3.2Product code LY3314814
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Yet Available
    D.3.9.2Current sponsor codeLY3314814
    D.3.9.3Other descriptive nameLY3314814
    D.3.9.4EV Substance CodeSUB181816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early Alzheimer's Disease (mild cognitive impairment due to AD (ie, prodromal AD) and mild dementia of the Alzheimer's type)
    E.1.1.1Medical condition in easily understood language
    Early Alzheimer's Disease
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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 disease modification as outlined in Liu-Seifert (2015). This will be accomplished by testing the three delayed-start hypotheses in both doses of LY3314814 across Study AZES and up to Week 26 (Visit 7) of Study AZFD.
    E.2.2Secondary objectives of the trial
    1. To evaluate the disease modification of both
    doses of LY3314814 on functional and cognitive outcomes across Study AZES and up to Week 26 (Visit 7) of Study AZFD using the primary analysis methodology.
    2. The delayed start analyses as outlined above will also be examined throught Week 104(Visit 15) for cognitive and functional outcomes.
    3. Collect information in order to further
    characterize the safety and tolerability of
    LY3314814 in patients with early AD
    dementia (at the time of entry into Study
    AZES)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To evaluate the effect of LY3314814 on brain amyloid burden using positron emission tomography (PET) in the longitudinal PET sub-study (included in the main protocol).
    - Protocol Addendum I8D-MC-AZFD(1.1) - FDG PET Imaging biomarker, v 12-Jul-2017 The objectives are to evaluate the effect of LY3314814 on brain metabolic rates using FDG
    PET and to evaluate change from baseline (in Study AZES) in brain metabolism as measured by FDG PET.
    - Protocol Addendum I8D-MC-AZFD (2.1) - Flortaucipir F 18 (18F-AV-1451) Tau PET Imaging Biomarker, v 12-Jul-2017. The objective is to evaluate change from baseline (in Study AZES) in tau as measured by flortaucipir F 18 PET.
    -Protocol Addendum I8D-MC-AZFD(3.1)
    Genetics v 12-Jul-2017: being conducted to collect and store whole blood
    deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) samples for future investigation of
    variable response to LY3314814 and genetic variants thought to play a role in Alzheimer’s
    disease (AD) and neurodegeneration.
    E.3Principal inclusion criteria
    Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed start I8D-MC-AZFD
    E.4Principal exclusion criteria
    Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
    E.5 End points
    E.5.1Primary end point(s)
    1. Delayed start analysis on the ADAS-Cog13
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. V. 5, 7 and at early discontinuation
    E.5.2Secondary end point(s)
    1. Delayed start analysis on the ADCS-iADL
    2. Delayed start analysis on the FAQ
    3. Delayed start analysis on the iADRS
    4. Delayed start analysis on the MMSE
    5. Delayed start analysis on the ADAS-Cog13

    Standard safety assessments:
    6. Spontaneously reported AEs
    7. Clinical laboratory tests
    8. Vital signs
    9. Body weight
    10. 12-lead ECGs
    11. Physical examinations including neurological examinations

    Additional safety assessments:
    12. Eye examinations
    13. Skin examinations
    14. Serial MRI
    15. Columbia-Suicide Severity Rating Scale (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. V. 7, 11, 13, 15 & early discontinuation
    2. V. 7, 11, 13, 15 & early discontinuation
    3. V. 7, 11, 13, 15 & early discontinuation
    4. V. 5, 7, 11, 13, 15 & early discontinuation
    5. V. 5, 7, 11, 13, 15 & early discontinuation
    6, As observed
    7. V. 3, 4, 5, 7, 9, 11, 12, 13, 14, 15 & early discontinuation
    8. V. 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 & early discontinuation & follow-up
    9 V. 5, 7, 11, 15 & early discontinuation
    10. V. 2, 3, 5, 7, 9, 11,13,15 & early discontinuation &f ollow-up
    11. V. 3, 5, 7, 9, 11,12, 13, 14, 15 & early discontinuation
    12. V. 11,15 & early discontinuation
    13. V. 5, 11, 15 & early discontinuation
    14. V. 11, 15 & early discontinuation
    15. V. 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 & early discontinuation & follow-up
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    LY3314814 either 20 mg or 50 mg
    E.8.2.4Number of treatment arms in the trial4
    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 concerned113
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA113
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Poland
    Romania
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months4
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1115
    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 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
    Represented by their legal representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state594
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 594
    F.4.2.2In the whole clinical trial 1400
    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)
    As defined in the 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 Decision2017-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-02
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