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    Summary
    EudraCT Number:2008-007926-21
    Sponsor's Protocol Code Number:H8A-MC-LZAN(b)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-13
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-007926-21
    A.3Full title of the trial
    Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo
    A.4.1Sponsor's protocol code numberH8A-MC-LZAN(b)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    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 nameSolanezumab
    D.3.2Product code LY2062430
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNSolanezumab
    D.3.9.2Current sponsor codeLY2062430
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer’s Disease
    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 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
    The primary objective of this study is to test the hypothesis that intravenous infusion of LY2062430 will slow the decline of AD as compared with placebo, as assessed at 80 weeks after initiation of treatment using a mixed-model repeated-measures (MMRM) analysis of 2 coprimary outcomes, the 11 item Alzheimer’s Disease Assessment Scale—Cognitive subscore (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study—Activities of Daily Living Inventory (ADCS-ADL). The specific hypothesis is that the change at the end of the treatment phase for LY2062430 will be significantly less than that for placebo.
    E.2.2Secondary objectives of the trial
    To assess global clinical benefit of treatment as demonstrated through CDR-SB and NPI
    To provide supporting evidence that LY2062430 attenuates the underlying pathologic process in AD by vMRI to assess the rate of decline in brain volumes
    To compare the safety of LY2062430 and placebo
    To characterize population pharmacokinetics
    To test the hypothesis that LY2062430 will slow the rate of decline associated with AD compared with placebo using ADAS-Cog11, ADCS-ADL, ADAS-Cog12, ADAS-Cog14 and MMSE
    To assess clinical benefit of treatment with LY2062430 as demonstrated through RUD-Lite, EQ-5D Proxy, and QoL-AD scale
    To assess differential rate of functional decline with LY2062430 compared with placebo using a subset of items from the ADCS-ADL for instrumental ADLs
    To provide further supporting evidence that LY2062430 attenuates the underlying pathologic process in AD as measured by several additional biomarkers that will be collected via optional study addenda
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: H8A-MC-LZAN (1) (Sample Banking) Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo.
    Date: 07 October 2008 Version: 1
    Objective: Eli Lilly and Company has established a program, Combined Specimen Banking (CSB), to bank samples from patients enrolled in studies sponsored by Eli Lilly and Company. The Banked Samples are collected and banked for research to identify the (1) genes, (2) gene products, (3) biochemical markers, or (4) any combination thereof associated with diseases, response to clinical trial medication, or both or other medication taken during the trial.

    Title: H8A-MC-LZAN (2) (Lumbar Punctures) Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo
    Date: 07 October 2008 Version: 1
    Objectives: Lumbar punctures (LPs) will be used to collect cerebrospinal fluid (CSF) for assays of CSF glucose, protein, cell count with differential, and albumin; LY2062430, amyloid β peptides (Aβ), and tau proteins and CSF storage. A secondary objective of the study is to show that concentrations of free (unbound to antibody) Aβ1-42 in CSF may be increased in LY2062430-treated patients compared with placebo-treated patients.

    H8A-MC-LZAN (3) (Amyloid Imaging)Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo
    Date: 22 December 2008
    This technique will be used in this study to meet 2 secondary study objectives: first, to test the hypothesis that amyloid burden will be reduced in patients treated with
    LY2062430 (versus placebo) and second, that only patients demonstrating sufficient
    amyloid burden at baseline will respond to treatment as determined by clinical measures
    E.3Principal inclusion criteria
    1.Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD (McKhann et al. 1984; Protocol Attachment LZAN.3) as determined by a neurologist or geriatrician.
    2.Has a Modified Hachinski Ischemia Scale (MHIS; Hachinski et al. 1975; Protocol Attachment LZAN.3) score of ≤4.
    3.Has a Folstein MMSE score of 16 through 26 at Visit 1 (Folstein et al. 1975; Protocol Attachment LZAN.3).
    4.Has a Geriatric Depression Scale (GDS) score of ≤6 (on the staff-administered short form).
    5.Has had an MRI or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD. Results of this MRI or CT are to be on file at the site. If a patient has not had a prestudy MRI/CT scan in the past 2 years or attempts to obtain offsite imaging results are unsuccessful, then a screening non-contrast head CT is to be performed; due diligence to obtain offsite results should be documented in the patient’s file before obtaining a screening non-contrast head CT scan or MRI scan. Alternatively, the MRI scan required prior to solanezumab administration at Visit 2 may be used to assess eligibility upon approval by the Medical Monitor.
    6.Is at least 55 years old, and if a female of childbearing potential, tests negative for pregnancy at Visit 1 and is using a medically accepted means of contraception.
    7.If receiving concurrent treatment with an AChEI and/or memantine, has been on the medication for at least 4 months with a stable dose for at least 2 months before Visit 2. Dosing must remain stable throughout the study.
    E.4Principal exclusion criteria
    [8] Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.
    Note: The caregiver(s) must be able to communicate with site personnel and be willing to comply with protocol requirements, and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. Participants living in an assisted-living facility may be included if study medication intake is supervised and if regular contact with a caregiver who accompanies the patient is maintained. If it is known that the caregiver could change and the two caregivers are available (in the same location) both should be advised of the study procedures and may attend the visits with the patient. In addition, both will have to sign the Informed Consent Document (ICD) (see section 13.1).
    [9] Meets National Institute of Neurological Disorders and Stroke/ Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia (detailed in Protocol Attachment LZAN(a).3).
    [10] Does not have good venous access, such that intravenous drug delivery or multiple blood draws would be precluded.
    [11] Has current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years.
    [12] Has had multiple episodes of head trauma, or a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness.
    Solanezumab H8A-MC-LZAN(a) Protocol Amendment
    Confidential
    [13] Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate specific antigen (PSA) posttreatment.
    [14] Has allergies to humanized monoclonal antibodies.
    [15] Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
    [16] Has a history of chronic alcohol or drug abuse/dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 5 years.
    [17] Is clinically judged by the investigator to be at serious risk for suicide.
    [18] Has a recent (within 6 months before screening) or current laboratory result (if available) indicating a clinically significant laboratory abnormality as determined by the investigator.
    [19] Has ECG abnormalities obtained at Visit 1 that, in the opinion of the investigator, are clinically significant with regard to the patient’s participation in the study. Bazett’s corrected QT [QTcB] interval must be evaluated and must not exceed >458 msec in males or >474 msec in females.
    [20] At Visit 1, has alanine transaminase (ALT/SGPT) values ≥2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values ≥3 times the ULN, or total bilirubin values ≥2 times the ULN.
    [21] Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
    [22] Has received AChEIs, memantine and/or other Alzheimer’s disease therapy for less than 4 months or has less than 2 months of stable therapy on these treatments by Visit 2. (Note: If a patient has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before Visit 2.)
    [23] Has received medications that affect the central nervous system (except treatments for AD) for less than 4 weeks; that is, doses of chronic medications that affect CNS should be stable for at least 4 weeks before Visit 2.
    [24] Has had IgG therapy (sometimes called gamma globulin therapy) within the last year. Has previously completed or withdrawn from this study or previous participation in any other study investigating active immunization against AB.
    [25] Requires treatment with other monoclonal antibodies.
    Please refer to protocol for complete list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Each of the 2 coprimary endpoints, ADAS-Cog11 and the ADCS-ADL, will be analyzed separately using an MMRM analysis. The change from baseline score at each visit postbaseline during the treatment period will be the dependent variable. The model for the fixed effects will include 8 terms: baseline score, investigator, treatment, MMSE stratification factor at baseline (mild or moderate), visit, treatment-by-visit interaction, concomitant AChEI or memantine use at baseline (yes/no), and age at baseline. Visit will be considered a categorical variable with values equal to the visit numbers at which the scales were assessed. The null hypothesis is that the contrast between the LY2062430 group versus placebo at the last visit equals zero. A rejection of the null hypothesis in favor of the alternative, showing that LY2062430 is superior to placebo, will demonstrate a treatment effect
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) 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 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.8.3 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    provided in protocol
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=65 years) Yes
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 1000
    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 Decision2009-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-20
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