Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-003973-16
    Sponsor's Protocol Code Number:CCAD106A2201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-19
    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 number2007-003973-16
    A.3Full title of the trial
    A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable.
    A.4.1Sponsor's protocol code numberCCAD106A2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 nameCAD106
    D.3.2Product code CAD106A
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCAD106A
    D.3.9.3Other descriptive nameCAD106
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Yes
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild Alzheimer's Disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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 safety and tolerability of repeated subcutaneous (s.c.) injections of 150µg CAD106 in patients with mild Alzheimer's Disease (AD) over the 52 weeks of the study.
    E.2.2Secondary objectives of the trial
    • To determine the Aβ-specific antibody response to CAD106 by means of evaluating titer levels (IgG and IgM) in serum and in CSF; and assessing Qβ-specific antibody response: (IgG and IgM) in serum over the 52 weeks of the study.
    • To characterize Aβ-specific and Qβ-specific T-cell response in PBMCs from patients receiving CAD106 or placebo over the first 14 weeks of the study.
    • To evalutate the effect of CAD106 vs. placebo on the concentrations of disease related markers in patients with mild AD
    • To explore the effect of CAD106 compared to placebo on the progression of 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
    Exploratory biomarker sub-studies on pharmacogenetics and blood pharmacogenomics are detailed in the enclosed protocol (section 7.8). These sub-studies are optional as only performed on patients who agree to participate by signing a separate informed consent.

    Please see enclosed protocol, Section 7.8, for further details.
    E.3Principal inclusion criteria
    Key Inclusion criteria:

    • Male and/or female patients between 40 and 85 years of age (both inclusive).
    • Female patients must be without childbearing potential (post-menopausal or surgically sterilized).
    • Diagnosis of dementia of the Alzheimer’s type according to the DSM-IV criteria and satisfying the NINCDS-ADRA criteria for a clinical diagnosis of probable AD.
    • Mild AD as confirmed by MMSE score of 20 to 26 (both inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.
    • With sufficient education and able to provide written informed consent prior to study participation. Having support from a primary caregiver accepting to accompany the patient at visits and assess the patient’s condition.

    Please see enclosed protocol, section 5.1, for further details.
    E.4Principal exclusion criteria
    Key Exclusion criteria:

    • Any medical or neurological condition, other than AD, that contributes significantly to the patient’s dementia, including any CSF and/or cerebral MRI findings at screening.
    • History in the past two years or current diagnosis of CNS inflammation.
    • History or current diagnosis of significant cerebrovascular disease as defined by MRI central reader with a Hachinski score > 4.
    • >2 cerebral microhemorrhages.
    • History or current diagnosis of an active autoimmune disease.
    • Current diagnosis of a clinically relevant atopic condition (e.g. moderate or severe asthma).
    • Evidence of current inflammation or of any acute disease or infection in past 4 weeks, including fever (>38°C) in the 3 days prior to the first injection.
    • History of immunocompromise, or testing positive for Hepatitis B or Hepatitis C.
    • Vital signs outside of normal ranges for their age group
    • History of any severe or unstable cardiovascular disease, including QTc ≥ 450msec in males or ≥ 470msec in femals.
    • Treatment with any of the following substances:
    - in the 3 months prior to first injection:
    • any investigational drug; any drug or treatment known to cause major organ system toxicity;
    - in the 4 weeks prior to first injection:
    • de novo initiation of treatment or change of dose of current treatment with cholinesterase-inhibitors and/or memantine;
    • start of treatment with psychotropic medication (with the exception of mild hypnotic drugs, and low doses of neuroleptic drugs);
    • treatment with centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants;
    • de novo initiation of treatment or change in dosage of non-anticholinergic antidepressants;
    • change in dose of current treatment with peripheral anticholinergics;
    • initiation of therapy with anticoagulants or antiplatelet agents, however, acetylsalicylic acid is permitted;
    - in the 2 weeks before and after any of the three injections:
    • any other immunization
    • Participation in any other AD immunotherapy study receiving active treatment.
    • Treatment in the previous 5 years with immunosuppressive drugs, except local application of steroids.
    • History of alcohol or drug abuse within the last 2 years and/or current alchol/drug abuse.
    • Contraindication to MRI investigations and/or lumbar puncture.
    • Patients who have been declared mentally incompetent.

    Please see enclosed protocol, section 5.1, for further details.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to establish the safety and tolerability of repeated injections of 150µg of CAD106.

    For the analysis of the primary objective, the following variables will be analysed:
    • Frequency of adverse events.
    • Frequency of cerebral MRI and CSF findings related to either inflammation, vasogenic edema or microhemorrhages.
    • Frequency of injection-related reactions from the patient’s diary.

    Please see enclosed protocol, section 10.4, for further details.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Determine Aβ- and Qβ-specific antibody titers in serum and in CSF (IgM and IgG).
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    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)
    A protocol amendment implementing additional safety follow-up visits for further two years will be finalized before the first patient completes the study. A separate informed consent will be provided for this Amendment.

    Please see enclosed Protocol section 6.6.7 for further details.
    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 Decision2008-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 19:53:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA