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    Summary
    EudraCT Number:2010-019895-66
    Sponsor's Protocol Code Number:WN25203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-019895-66
    A.3Full title of the trial
    Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer`s Disease.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberWN25203
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorF. Hoffmann-La Roche Ltd
    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.3.2Product code RO490-9832/F08
    D.3.4Pharmaceutical form Powder 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 codeRO490-9832/F08
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 typeAnticorpo umano ricombinante anti-Abeta
    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 placeboPowder for solution 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
    Prodromal 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 10066571
    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 effect of gantenerumab vs. placebo on the change in the Clinical Dementia Rating scale Sum of Boxes(CDR-SOB), a global measure of cognition and functional ability.
    E.2.2Secondary objectives of the trial
    -Cognition and functioning: To evaluate the effect of gantenerumab vs. placebo on cognition (assessed with the ADAS-Cog, MMSE, and CANTAB), on functioning (assessed with the FAQ), on neuropsychiatric functioning (assessed with the NPI-Q) and on onset of dementia. -Safety: To assess the safety and tolerability of gantenerumab assessed by MRI imaging, physical and neurological examinations, vital signs, blood and urine safety tests, ECGs and adverse event monitoring. - MRI volumetry: To evaluate the effect of gantenerumab vs. placebo on hippocampal volume, whole brain volume, ventricular enlargement, and possibly other volumetric measures. -Genotyping: To evaluate the effect of APOE ε4 genotype and Fcγ receptor genotype on PK/PD, efficacy and safety parameters. -Pharmacokinetics: To determine the relationship of plasma and CSF concentrations of gantenerumab on other responses. Et al..
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI: Progetto di ricerca associato al protocollo WN25203 “Conservazione dei campioni di CSF per lo sviluppo di saggi per i biomarcatori" - Protocollo WE25462 del 30 giugno 2010.
    E.3Principal inclusion criteria
    1. Written consent signed by the subject (co-signed by the subject’s next of kin or study partner, if required by the local regulations/guidelines/EC/IRB). 2. Age: 50-80. 3. Males or females of non-childbearing potential (more than two years after the cessation of menses or surgically sterile by means of hysterectomy, bilateral oopherectomy or tubal ligation). Additional blood tests will be done if required by the local regulations/guidelines/EC/IRB for further confirmation of non-childbearing potential. 4. Has a study partner who in the investigator`s judgment is able to provide accurate information as to the subject`s cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion, and who signs the necessary consent form if applicable. 5. Fluent in the language of the tests used at the study site. 6. Has had sufficient education or work experience to exclude mental retardation. 7. Willing to complete all aspects of the study (including MRI, lumbar puncture and genotyping) and capable of doing so either alone or with the help of the study partner 8. Not currently being treated with approved marketed medications for AD and the study physician does not anticipate any treatment with one during the study. 9. If not already aware, willing to have their ApoE genotype status withheld until the study is unblinded unless required by the relevant health authority or EC/IRB. If informing the subject of their ApoE status is required, the informed consent may be reviewed and re-signed before treatment begins. 10. Visual and auditory acuity sufficient to perform the cognitive tests (Eye glasses and hearing aids are permitted.) 11. Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after final dose. Et al..
    E.4Principal exclusion criteria
    CNS Disorders: 1. Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning including but not limited to: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral / spinal hematoma, inflammatory disease, CNS infection (e.g. encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes) or endocrine disorder. 2. A history of stroke. 3. A documented history of TIA within the last 12 months. 4. History of schizophrenia, schizoaffective disorder or bipolar disorder 5. Currently meets criteria for major depression. 6. Any other psychiatric condition/disorder which could significantly interfere with the subject’s cooperative participation (e.g., prominent anxiety, agitation or behavioral problems). 7. Current evidence or history of substance abuse disorder (DSM-IV) within 2 years. Imaging related criteria: 8. As assessed by the central reader, MRI evidence of a) more than one lacunar infarct, b) territorial infarct or macroscopic hemorrhage, or c) any deep white matter lesion corresponding to an overall Fazekas score of 3 which requires at least 1 confluent hyperintense lesion on the FLAIR sequence which is 20 mm or greater in any dimension 9. The combined number of microbleeds and areas of leptomeningeal hemosiderosis on MRI is more than 2 on a 1.5T machine or more than 3 on a 3T machine based on the review done by the central reader. 10. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan. Cardiovascular Disorders: 11. History of atrial fibrillation except if only one episode which resolved more than three years ago and for which treatment is no longer indicated. 12. Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g. myocardial infarction, angina pectoris, NYHA Class II or more cardiac failure). 13. Any single QTcF above 470 msec, or a difference of more than 30 msec in QTcF between triplicate ECGs at screening; clinically relevant abnormalities on screening ECG based on centralized reading (e.g., QRS equal or longer than 120 msec; multifascicular block; AV block II). 14. Uncontrolled hypertension (i.e. blood pressure generally >160 systolic or >95 mmHg diastolic). Et al...
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Clinical Dementia Rating Sum of Boxes (CDR SOB) score at week 104.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers, Explanatory Biomarkers, Clinical Genotyping
    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 Yes
    E.8.1.7.1Other trial design description
    studio esplorativo
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    La fine dello studio corrispondera` alla data dell’ultima visita (inclusa l`ultima visita di follow-up) dell’ultimo paziente incluso nello studio.
    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 months4
    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 months4
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 372
    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 Decision2010-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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