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    Summary
    EudraCT Number:2011-002133-20
    Sponsor's Protocol Code Number:ELN115727-351
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-002133-20
    A.3Full title of the trial
    A Phase 3 Extension, Multicenter, Double-Blind, Long Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer's Disease Who Participated in Study ELN115727-301 or in ELN115727-302
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term safety and tolerability study of bapineuzumab in patients with Alzheimer's Disease
    A.4.1Sponsor's protocol code numberELN115727-351
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00937352
    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 & Development, LLC
    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
    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.1.1.1Medical 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 14.0
    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
    To evaluate the long term safety and tolerability of IV administered bapineuzumab in subjects with Alzheimer's Disease.

    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.

    To evaluate the effect of long term treatment of IV administered bapineuzumab in subjects with AD on AD-related health outcomes (HO) and behavioral measures.

    To assess the immunogenicity of long term treatment of IV administered bapineuzumab and evaluate biomarkers that maybe indicative of disease modification in subjects with AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet ALL of the following criteria to be considered for enrollment into this study:

    1. Informed consent signed and dated by the caregiver, subject and/or by the subject’s legally acceptable representative according to local regulations.

    2. Must have completed all 6 infusions unless they were required to temporarily suspend study drug (eg, due to VE or special technical or medical considerations), but continued with their required visits in either Study 301 or 302, and have completed Visit 15/Week 78. Subjects with fewer than 6 infusions in Study 301 or 302 must obtain medical monitor approval.

    3. Brain MRI scan for the Radiologist to evaluate subject safety from Study 301 or 302 at Visit 14/Week71.

    4. 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 approximately 5 times per week for the duration of the study.

    5. In the opinion of the Principal Investigator, the risk:benefit ratio for participation in the trial is acceptable, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations, and the caregiver will be a reliable informant.

    6. CSF Participating Subjects only: Subjects must have completed a Visit 14/Week 71 lumbar puncture (LP) in the 301/302 Studies and consented to the CSF substudy in 351.
    E.4Principal exclusion criteria
    ANY one of the following will exclude a subject from being enrolled into the study:

    1. Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or electrocardiogram (ECG) examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study.

    2. Screening visit brain MRI scan (ie, MRI from Study 301 or 302 Visit 14 /Week 71) indicative of any significant abnormality, including but not limited to history or evidence of a single prior hemorrhage >1 cm3, more than 4 microhemorrhages (<10 mm), or evidence of a single prior infarct >1 cm3, cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (eg, brain tumors such as meningioma). NOTE: 351 Screening MRI Evaluation form is required on site prior to infusion. Subjects who have developed any of the above MRI abnormalities during Studies 301 or 302 may potentially be considered for Study 351 participation, however, approval by a medical monitor will be required prior to enrollment. An unblinded medical monitor may be used to exclude subjects with a history of any of the above MRI abnormalities or VE, if the MRI abnormalities, clinical findings or prior treatment assignment suggests potential safety concerns.

    3. Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginkgo biloba, and anticoagulants (except the use of aspirin 325 mg/day or less, Plavix, and Persantine but not for stroke).
    E.5 End points
    E.5.1Primary end point(s)
    • The incidence and severity of treatment-emergent adverse events (TEAEs)

    • Clinically important changes in safety assessment results including vital signs,
    weight, clinical laboratory tests, electrocardiograms (ECGs), brain MRI, physical and
    neurological examinations, and infusion site assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study or Early Termination
    E.5.2Secondary end point(s)
    • Change from Visit 2/Pre-Day 1 and Visit 15/Week 78 of Study ELN115727-301 (Study 301) or ELN115727-302 (Study 302) over time for the following scales: Alzheimer's Disease Assessment Scale–Cognitive subscale and Disability Assessment for Dementia

    • Change from Visit 1/Screening and Visit 15/Week 78 of Study 301 or 302 over time for the Mini Mental State Examination

    • Change from Visit 2/Pre-Day 1 and Visit 15/Week 78 of Study 301 or 302 over time for the following scales: Dependence Scale, Abbreviated Resource Utilization in Dementia, Health Utilities Index, Neuropsychiatric Inventory

    • Serum anti-bapineuzumab antibody levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study or Early Termination
    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 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 No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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
    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
    The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program whichever comes first
    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 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.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 929
    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'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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 1700
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
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