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    Summary
    EudraCT Number:2009-012748-17
    Sponsor's Protocol Code Number:ELN115727-301
    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:2009-06-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-012748-17
    A.3Full title of the trial
    A phase 3, multicenter, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety trial of bapineuzumab (AAB-001, ELN115727) in subjects with mild to moderate Alzheimer's disease who are apolipoprotein Eε4 non-carriers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating the Efficacy and Safety of Bapineuzumab in Alzheimer
    Disease Patients Who are Apolipoprotein Eε4 non-carriers.
    A.4.1Sponsor's protocol code numberELN115727-301
    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 SponsorJanssen Alzheimer Immunotherapy
    B.1.3.4CountryIreland
    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 supportJanssen Alzheimer Immunotherapy
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Alzheimer Immunotherapy Research &
    B.5.2Functional name of contact pointHead of Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address700 Gateway Blvd
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number888381 4595
    B.5.5Fax number650794 2504
    B.5.6E-mailmedicalinformation@janimm.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 nameBapineuzumab
    D.3.2Product code AAB-001
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNBapineuzumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAAB-001
    D.3.9.3Other descriptive nameanti-Abeta
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    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 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
    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 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
    Primary efficacy objective:

    To demonstrate the efficacy of multiple doses of IV-administered bapineuzumab
    (bapineuzumab IV; 0.5- and 1.0-mg/kg) compared to placebo in subjects with
    mild to moderate AD.
    Co-Primary Endpoints:
    The change from baseline to Week 78 in the Alzheimer’s Disease Assessment
    Scale – Cognitive subscale (ADAS-Cog/11) total score
    The change from baseline to Week 78 in the Disability Assessment Scale for
    Dementia (DAD) total score

    Safety Objective and Endpoints:
    To assess the safety of multiple doses of bapineuzumab IV compared to placebo
    in subjects with mild to moderate AD.
     The incidence and severity of treatment-emergent adverse events (TEAEs)
     Clinically important changes in safety assessment results (including, as
    appropriate, brain magnetic resonance imaging [MRIs], vital signs, weight,
    clinical laboratory tests, electrocardiograms [ECGs], and physical and
    neurological examinations).
    E.2.2Secondary objectives of the trial
    To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on time to first clinically meaningful deterioration in subjects with mild to moderate AD.

    To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on subject dependence in subjects with mild to moderate AD.

    To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on biomarkers that are indicative of disease pathophysiology in substudies of subjects with mild to moderate AD.

    To demonstrate divergence of effect (increasing separation with time compared
    with placebo) observed with multiple doses of bapineuzumab IV, in subjects with mild to moderate AD.

    To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on a global clinical assessment (Clinical Dementia Rating Sum of Boxes [CDR-SB]) in subjects with mild to moderate
    AD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Amend 5. Cerebrospinal fluid substudy:

    CSF will be collected from subjects who consent to this optional component of the study to assess levels of bapineuzumab, anti-bapineuzumab antibodies, pharmacodynamic endpoints, Aβ and tau; and, for safety information glucose, protein levels, and cell counts during screening and the week 71 (or ET).

    Amend 6. Pharmacogenomic substudy

    To obtain data for potential interpretation of pharmacodynamic efficacy, safety and tolerability measurements as necessary, and to allow for the characterisation of genetic factors associated with AD
    E.3Principal inclusion criteria
    SIGNED and dated written informed consent obtained from the subject or the subject’s legally acceptable representative (if applicable) in accordance with the local regulations. The subject’s caregiver must also consent to participate in the study.
    AGE from 50 to < 89 years.
    DIAGNOSIS of probable Alzheimer’s Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
    MINI-Mental State Examination (MMSE) score of 16-26, inclusive.
    ROSEN Modified Hachinski Ischemic score ≤4.
    LIVES at home with appropriate caregiver capable of accompanying the subject on all clinic visits or; lives independently in community dwelling and has caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study.
    SCREENING visit brain MRI scan consistent with the diagnosis of AD.
    FLUENCY in local language and evidence of adequate premorbid intellectual functioning.
    SUBJECT must have adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
    RECEIVING stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed if the following conditions are met: (a) subject is maintained on a stable dose regimen for at least 120 days prior to screening; (b) subject is free of any clinically significant side effects attributable to the drug; and (c) subject and caregiver agree that, barring unforeseen circumstances, they will continue the same regimen for the duration of the trial.
    WILLING to undergo ApoE testing and agree to disclosure of ApoE4 status.
    NON-carrier of ApoE4 allele according to genotyping at screening.
    IN the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study, including all scheduled evaluations and required tests.
    THE caregiver must be a reliable informant in the opinion of the investigator
    E.4Principal exclusion criteria
    HAS significant neurological disease, other than AD, that may affect cognition.
    HISTORY of or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages (2 or more), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more), or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (eg, arachnoid cysts or brain tumors such as meningioma). NOTE: the MRI scan shall be interpreted by a local radiologist and a central radiologist prior to enrolling the subject. Both local and central interpretations shall be reviewed by the investigator for determination of subject eligibility.
    CURRENT presence of a clinically significant major psychiatric disorder (eg, Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) or symptom (eg, hallucinations) that could affect the subject’s ability to complete the study.
    CURRENT clinically significant chronic illness which is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study.
    HISTORY of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
    HISTORY of seizures, excluding febrile seizures in childhood.
    WEIGHT greater than 120kg (264lbs).
    HISTORY or evidence of any clinically significant autoimmune disease or disorder of the immune system (eg, Crohn’s Disease, Rheumatoid Arthritis).
    CLINICALLY significant infection within the last 30 days eg, chronic persistent or acute infection (eg, upper respiratory infection, urinary tract infection).
    TREATMENT with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.
    MYOCARDIAL infarction within the last 2 years.
    HISTORY of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin.
    UNCONTROLLED hypertension within the last 6 months.
    OTHER clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination that could compromise the study or be detrimental to the subject.
    HEMOGLOBIN less than 11g/dL.
    SUBJECTS who have donated blood (routine blood donation) in the 30 days prior to screening.
    EXCESSIVE smoking defined as >20 cigarettes per day.
    HISTORY of alcohol or drug dependence or abuse as defined by DSM-IV criteria within the last 2 years.
    CURRENT use of anticonvulsant drugs for seizures, antiparkinson drugs, anticoagulant medications (except the use of aspirin 325 mg/day or less, plavix, and persantine but not for stroke), or opioid pain relievers and related synthetic derivatives.
    CURRENT use of prescription or nonprescription medication for cognitive enhancement, other than cholinesterase inhibitors and memantine as previously described.
    HAS discontinued cholinesterase inhibitors, memantine, or cognitive enhancing agents within 60 days prior to screening, or drugs that potentially affect cognition in the 30 days prior to screening (including but not limited to anxiolytics, sedatives, hypnotics, antipsychotics, herbal preparations, antidepressants, over-the-counter sleeping aids, sedating anti-allergy medications, vitamin E, thyroid supplements, vitamin B12 supplements by injection).
    UNLESS maintained on a stable dose regimen for at least 30 days prior to screening, any other medications with the potential to affect cognition other than cholinesterase inhibitors or memantine.
    USE of experimental medications for AD or any other investigational medications or devices for treatment of indications other than AD within 60 days prior to screening or within 5 half-lives of use of such a medication prior to screening, whichever is longer.
    ANY prior experimental treatment with AN1792, bapineuzumab, ACC 001 or other experimental immunotherapeutic or vaccine for AD.
    ANY prior treatment with a biological product other than for the treatment of AD within the last 3 years with the exception of yearly routine vaccine(s) that is (are) commercially available.
    ANY known hypersensitivity to any of the excipients contained in the study drug formulation.
    WOMEN of childbearing potential.
    PRESENCE of pacemakers, aneurysm clips, artificial heart valves, ear implants, CSF shunts, claustrophobia, metal fragments or foreign objects in the eyes, skin, or body that would contraindicate a brain MRI scan.
    DO not have adequate venous access that would allow intravenous drug delivery or multiple blood draws.
    E.5 End points
    E.5.1Primary end point(s)
    ADAS-Cog and DAD
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Austria
    Canada
    Germany
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.3Elderly (>=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 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
    Subject's with Alzheimer's Disease may need consent from a legally acceptable representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 1450
    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)
    Subjects may continue or initiate commercially available medications for their condition after study participation
    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 Decision2009-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-05
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