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    Summary
    EudraCT Number:2011-005217-37
    Sponsor's Protocol Code Number:I4O-MC-BACC(b)
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-005217-37
    A.3Full title of the trial
    Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
    A.4.1Sponsor's protocol code numberI4O-MC-BACC(b)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01561430
    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
    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 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 Information
    B.5.3 Address:
    B.5.3.1Street AddressClinical Trial Information
    B.5.3.2Town/ cityClinical Trial Information
    B.5.3.3Post codeClinical Trial
    B.5.3.4CountryUnited Kingdom
    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 nameLY2886721
    D.3.2Product code LY2886721
    D.3.4Pharmaceutical form Capsule
    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 INNLY2886721
    D.3.9.1CAS number 1262036-50-9
    D.3.9.2Current sponsor codeLY2886721
    D.3.9.3Other descriptive nameLY2886721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 nameFlorbetapir (18F)
    D.3.2Product code Florbetapir (18F)
    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 codeflorbetapir F 18, AMYViD
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number720 to 2090
    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.IMP: 3
    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 nameLY2886721
    D.3.2Product code LY2886721
    D.3.4Pharmaceutical form Capsule
    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 INNtbc
    D.3.9.1CAS number 1262036-50-9
    D.3.9.2Current sponsor codeLY2886721
    D.3.9.3Other descriptive nameLY2886721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 placeboCapsule, hard
    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
    Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the cerebrospinal fluid (CSF) pharmacodynamic (PD) effect of LY2886721 doses in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD compared to placebo, measured by change of CSF Aβ1 40 and Aβ1 42 concentrations from baseline to Week 12 and Week 26.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of LY2886721 over 26 weeks.
    To compare cerebral vasogenic edema (ARIA-E) and cerebral microhemorrhage (ARIA-H) using fluid attenuation inversion recovery (FLAIR) and T2*w MRI associated with different doses of LY2886721 treatment or placebo
    To assess the plasma PD effect of different LY2886721 doses compared to placebo, measured by change of plasma Aβ1-40 & Aβ1-42
    concentrations from baseline to Week 12 and 26.
    To assess the effect of 2 doses of LY2886721 compared to placebo on the cognitive and behavioral symptoms of AD measured by
    Neuropsychological Test Battery (NTB), AD Assessment Scale – Cognitive subscale (ADAS-Cog), Mini Mental State Examination (MMSE), &
    Neuropsychiatric Inventory (NPI).
    To assess the effect of 2 doses of LY2886721 compared to placebo on the global rating of symptoms of AD measured by the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB).
    To assess change from baseline to Week 12 and 26 for cSF tau and ptau181.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Present with MCI due to AD or mild AD based on the disease diagnostic criteria
    [2] Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years. Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods.
    [3] Have a reliable caregiver/study informant who provides a separate written informed consent to participate and who has sufficient contact with the patient to provide information about the patient’s daily activities. The caregiver/study informant must be able to communicate with site personnel and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. If a caregiver/study informant cannot continue, 1 replacement is allowed.
    [4] Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
    [5] Have adequate premorbid literacy in the investigator’s opinion to complete the required psychometric tests
    [6] Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

    Disease Diagnostic Criteria
    Patients with MCI due to AD or mild AD will be selected according to the following criteria:
    - Gradual and progressive change in memory function reported by patient or caregiver/study informant over more than 6 months.
    - Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test with Immediate Recall (FCSRT – IR): ≤16 for free recall or ≤40 for total recall. The episodic memory impairment can be isolated or associated with other cognitive changes at the onset of AD or as AD advances.
    - Clinical Dementia Rating Scale (CDR) = 0.5 or 1, memory box score ≥0.5
    - Mini Mental State Examination (MMSE) 20 to 30
    - florbetapir F18 scan positive for the presence of Aβ(based on central review)
    E.4Principal exclusion criteria
    •Participant in another drug or device study
    •Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease or Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
    •Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than two months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed
    •Have had a serious infectious disease affecting the brain in the past 5 years
    •Have had a serious or repeat head injury
    •Have significant retinal impairment or disease
    •Have had a stroke or other circulation problems that are affecting your current health
    •Have had a positron emission tomography (PET) scan in the past 6 months
    •Have had a seizure
    •Have major depressive disorder (participation is allowed if depressive symptoms are treated with stabile administration of antidepressants) or another mental illness such as schizophrenia or bipolar disorder
    •History of alcohol or drug abuse
    •Have asthma, chronic obstructive pulmonary disease (COPD) or other breathing disease that is not controlled with medicine
    •Have human immunodeficiency virus (HIV) or syphilis
    •Have any medical condition requiring double and triple anti-platelet treatment (for example, combination of aspirin with Clopidogrel, and/or Cilostazol). Note: single antiplatelet therapy is not an exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    •Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 12 weeks]
    •Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 26 weeks]
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 12 weeks]
    •Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 26 weeks]
    E.5.2Secondary end point(s)
    •Change from baseline in plasma amyloid beta (Aβ)1-40 and Aβ1-42 concentrations
    •Change from baseline to 26 weeks in Neuropsychological Test Battery (NTB)
    •Change from baseline to 26 weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
    •Change from baseline to 26 weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
    •Change from baseline to 26 weeks in Mini Mental State Examination (MMSE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Change from baseline in plasma amyloid beta (Aβ)1-40 and Aβ1-42 concentrations [Time Frame: Baseline, 12 weeks, 26 weeks ]
    •Change from baseline to 26 weeks in NTB [Time Frame: Baseline, 26 weeks]
    •Change from baseline to 26 weeks in ADAS-Cog [Time Frame: Baseline, 26 weeks ]
    •Change from baseline to 26 weeks in the CDR-SB [ Time Frame: Baseline, 26 weeks ]
    •Change from baseline to 26 weeks in MMSE [Time Frame: Baseline, 26 weeks ]


    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 Yes
    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 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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Italy
    Japan
    Netherlands
    Spain
    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
    Last Patient Last visit
    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 months3
    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 months11
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with Alzheimer's Disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 260
    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 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 Decision2012-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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