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    Summary
    EudraCT Number:2007-005994-79
    Sponsor's Protocol Code Number:3133K1-3000-WW
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-31
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-005994-79
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-carriers
    A.4.1Sponsor's protocol code number3133K1-3000-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.3.4Pharmaceutical 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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 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
    To investigate efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and the Disability Assessment for Dementia (DAD) (co-primary measures).
    E.2.2Secondary objectives of the trial
    To investigate the safety and efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Neuropsychological Test Battery (NTB) and the Clinical Dementia Rating Sum of Boxes (CDR-SOB) (key secondary measures). Safety objectives include the incidence and severity of treatment-emergent adverse events (TEAEs), and clinically important changes in safety assessment results.
    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 volumetric MRI substudy, a cerebrospinal fluid (CSF) substudy, an amyloid PET substudy, and an FDG-PET substudy.

    Objectives:
    To evaluate the effect of multiple doses of IV administered bapineuzumab compared with placebo on biomarkers that may be indicative of disease modification in subsets of subjects with mild to moderate AD:
    • The change from baseline total tau or phospho-tau levels in the CSF to week 71 in a subset of subjects.
    • The change from baseline brain boundary shift integral (BBSI) assessed by MRI to week 71 in a subset of subjects.
    • The change from screening whole brain volume (WBV), ventricular volume (VV), and ventricular boundary shift integral (VBSI) to week 71 as assessed by MRI• The change from baseline brain amyloid burden to week 71 assessed by amyloid PET imaging in a subset of subjects.
    • The change from baseline brain glucose metabolism to week 71 assessed by FDG PET imaging in a subset of subjects.

    To evaluate the PD profile of multiple doses of IV administered bapineuzumab in subjects with mild to moderate AD versus placebo, including
    • In a subset of subjects, the change from baseline to week 71 in Aβ concentrations in the CSF and plasma.

    To evaluate the population PK profile and parameter estimates in subjects with mild to moderate AD receiving multiple doses of IV administered bapineuzumab, including
    • CSF concentrations of bapineuzumab, at baseline and at week 71, for a subset of subjects.

    To assess the immunogenicity of multiple doses of IV administered bapineuzumab in subjects with mild to moderate AD, including
    • In a subset of subjects, CSF antibapineuzumab antibody levels.
    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) Man or surgically sterile or postmenopausal woman, aged ≥50 to <89 years.
    3) Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
    4) MMSE score of 16 to 26, inclusive.
    5) Rosen Modified Hachinski Ischemic Score ≤4.
    6) Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with 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.
    7) Screening visit brain MRI scan consistent with the diagnosis of AD.
    8) Fluency in local language and evidence of adequate premorbid intellectual functioning.
    9) Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
    10) Receiving stable doses of medication(s) for the treatment of nonexcluded medical condition(s) for at least 30 days prior to screening, and, if treated with cholinesterase inhibitors and/or memantine, all of the following conditions are also met: (a) The subject is maintained on a stable dose regimen for at least 120 days prior to screening. (b) The subject is free of any clinically important side effects attributable to the drug. (c) The subject and caregiver agree that, barring unforeseen circumstances, they will continue the same regimen for the duration of the trial.
    11) The subject and caregiver are likely to be able to participate in all scheduled evaluations and complete all required tests.
    12) Willing to undergo apolipoprotein E (ApoE) testing and agree to disclosure of ApoE4 status.
    13) Noncarrier of ApoE4 according to genotyping at screening (ie, has zero copies of ApoE4).
    14) In the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study.
    E.4Principal exclusion criteria
    1) Significant neurologic disease, other than AD, that may affect cognition.
    2) History of or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages (two or more), evidence of a single prior hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or space-occupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma).
    NOTE: the screening MRI scan shall be interpreted by a local radiologist and a central radiologist prior to enrolling the subject. Both interpretations shall be reviewed by the investigator for determination of subject eligibility relative to Inclusion Criteria #7 and Exclusion Criteria #2.
    3) Current presence of a clinically important major psychiatric disorder (eg, major depressive disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) or symptom (eg, hallucinations) that could affect the subject’s ability to complete the study.
    4) Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study.
    5) History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis or plaque.
    6) History of seizures, excluding febrile seizures in childhood.
    7) Weight greater than 120 kg (264 lb).
    8) History or evidence of any clinically important autoimmune disease or disorder of the immune system (eg, Crohn disease, rheumatoid arthritis).
    9) Clinically important infection within the last 30 days (eg, chronic persistent or acute infection, such as bronchitis or urinary tract infection [UTI]).
    10) 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.
    11) Myocardial infarction within the last 2 years.
    12) History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin.
    13) Uncontrolled hypertension within 6 months prior to screening.
    14) Other clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
    15) Hemoglobin level less than 11 g/dL.
    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 Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA145
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 1250
    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. A protocol extension is under consideration but not yet drafted.
    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 Decision2008-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Patient Information Sheet and consent form and procedure
    N.Date of Ethics Committee Opinion2009-10-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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