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    Summary
    EudraCT Number:2009-015079-29
    Sponsor's Protocol Code Number:3133K1-3002-WW
    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:2009-11-09
    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 number2009-015079-29
    A.3Full title of the trial
    A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW
    A.4.1Sponsor's protocol code number3133K1-3002-WW
    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 SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    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 nameAAB-001
    D.3.2Product code WAY 203740
    D.3.4Pharmaceutical form Solution for injection
    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 INNBapineuzumab
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAAB-001, WAY 203740
    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) 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 typeHumanized anti-Abeta peptide IgG1 monoclonal antibody
    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
    Alzheimer Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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 study 3133K1-3002-WW is to evaluate the long term safety and tolerability of intravenously administered bapineuzumab in subjects with Alzheimer Disease (AD) based on adverse events, scheduled vital signs, electrocardiogram parameters, clinical laboratory tests, brain MRI scans, physical and neurological examinations, and infusion site assessment. In addition, the studies will be continuously monitored by an independent safety monitoring committee.
    E.2.2Secondary objectives of the trial
    In order to explore the long-term effect of bapineuzumab in subjects with AD, exploratory efficacy measures in study 3002 will include Alzheimer’s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), Disability Assessment for Dementia (DAD), Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI) and health outcome assessments [Dependence Scale (DS), Resource Utilization in Dementia, version 2.4 (RUD Lite v2.4), and Health Utilities Index (HUI)].

    Biomarker objectives: please refer to section E.2.3 / E.2.3.1.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies are incorporated into the main protocol, and so do not have a separate title/date/version. Four substudies are included: a cerebrospinal fluid (CSF) substudy, a volumetric MRI substudy, a PET substudy and a biochemical characterization substudy.

    Objectives:
    To evaluate the effect of IV administered bapineuzumab on biomarkers in subsets of subjects with AD:
    • Amyloid (Pittsburgh Compound B (PIB)) and fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging.
    • Brain volumetrics by magnetic resonance imaging (MRI).
    • Aβ in cerebrospinal fluid (CSF) and plasma, total tau and phospho-tau levels in CSF.
    • Biochemical characterization of circulating bapineuzumab antibody will also be conducted in a subset of subjects, using immunoaffinity chromatography from patient sera.
    E.3Principal inclusion criteria
    1. 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.
    2. Subject has completed all 6 infusions planned in protocol 3133K1-3000; or, if the subject was required to temporarily suspend investigational product (e.g., due to vasogenic edema), he/she continued with required visits, has completed all study visits through the week 78 visit and his/her current status indicates that he/she resumed or is eligible to resume investigational product.
    NOTE: Subjects who developed vasogenic edema during study 3133K1-3000 may be considered for study 3133K1-3002 participation if the abnormality is resolved and the subject met criteria to resume investigational product. Medical monitor approval is required prior to enrollment.
    3. Brain MRI scan from week 71 of study 3133K1-3000 is available for local radiology and central radiology evaluation and remains consistent with the diagnosis of AD.
    4. MMSE score ≥10 at screening (week 78 of 3133K1-3000).
    5. Continues to live at home or community dwelling with appropriate caregiver capable of accompanying the subject on all clinic visits and visiting with the subject at least 5 days per week, on average for the duration of the study.
    6. In the opinion of the principal investigator, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations.
    E.4Principal exclusion criteria
    1. Any medical or psychiatric contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab, participation in the study or evaluation of the subject’s response.
    2. Brain MRI scan from study 3133K1-3000 week 71 visit indicative of any significant abnormality, including but not limited to multiple microhemorrhages (two or more), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarct (two 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 (e.g., arachnoid cysts or brain tumors such as meningioma).
    3. Use of any experimental medications, other than bapineuzumab, within the last 60 days prior to screening.
    4. Current use of herbal preparations containing ginkgo biloba, or use of anticoagulants.
    NOTE: Platelet anti-aggregants (e.g., the use of aspirin 325 mg/day or less, clopidogrel bisulfate, dipyridamole except for stroke) are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events, brain MRI scans, vital signs, ECG measurements, clinical laboratory tests, physical and neurological examinations, and infusion site assessment.
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparator or placebo not being used, but treatment allocation is blinded.
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA142
    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 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 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 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 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
    Subjects with Alzheimer disease may require consent from legally acceptable representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1000
    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)
    This is a 2-year extension protocol for patients who have completed 3133K1-3000-WW study (18 months).
    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 Decision2009-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-25
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