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    Summary
    EudraCT Number:2012-002764-27
    Sponsor's Protocol Code Number:NILVAD2012
    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:2013-02-04
    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 number2012-002764-27
    A.3Full title of the trial
    A European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild to Moderate Alzheimer's desease
    Studio Europeo multicentrico in doppio cieco per valutare l'efficacia di nilvadipina versus placebo nella malattia di Alzheimer da lieve a moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    European multicentre study to evaluate the efficacy and safety of nilvadipine in mild to moderate Alzheimer's desease
    Studio clinico condotto in diversi paesi europei per valutare l'efficacia e la sicurezza di nilvadipina nella malattia di Alzheimer da lieve a moderata
    A.3.2Name or abbreviated title of the trial where available
    NILVAD
    NILVAD
    A.4.1Sponsor's protocol code numberNILVAD2012
    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 SponsorST. JAMES HOSPITAL
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support7th Framework Programme European Commission
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche ''Mario Negri''
    B.5.2Functional name of contact pointNeuropsichiatria Geriatrica
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number+390239014427
    B.5.5Fax number+39023546277
    B.5.6E-mailugo.lucca@marionegri.it
    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 Yes
    D.2.1.1.1Trade name NIVADIL
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA Co.Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form Prolonged-release capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNILVADIPINE
    D.3.9.1CAS number 75530-68-6
    D.3.9.4EV Substance CodeSUB09292MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboProlonged-release capsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate Alzheimer's disease
    malattia di Alzheimer di grado da lieve a moderato
    E.1.1.1Medical condition in easily understood language
    Mild to moderate Alzheimer's disease (dementia)
    malattia di Alzheimer (demenza) da lieve a moderata
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10057167
    E.1.2Term Mental impairment disorders
    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
    investigating the effectiveness and safety of nilvadipine as a treatment able to modify the course of Alzheimer's disease of mild to moderate
    indagare l'efficacia e sicurezza di nilvadipina come trattamento in grado di modificare il decorso della malattia di Alzheimer di grado da lieve-moderato
    E.2.2Secondary objectives of the trial
    nessuno
    nessuno
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    Nilvad Frailty Sub study, 06/11 2012, v1 Objective: to define a valid frailty index (FI) in the Nilvad study patients before, during and after treatment.

    ALTRI SOTTOSTUDI:
    Studio ancillare sulla fragilità, 06/11/2012, v1 Obiettivo: definire un valido indicatore di fragilità nei pazienti inclusi nello studio Nilvad

    E.3Principal inclusion criteria
    Patients older than 50 years with a diagnosis of Alzheimer's disease according to the NINCDS-ADRDA criteria with a SMMSE test score greater than or equal to 12 and minor than 27.
    Pazienti di età superiore a 50 anni con diagnosi di malattia di Alzheimer secondo i criteri NINCDS-ADRDA con un punteggio al test SMMSE maggiore o uguale a 12 e minore di 27, soggetti in dose stabile (maggiore 3 mesi) inibitori delle colinesterasi e memantina.
    E.4Principal exclusion criteria
    Subjects treated with calcium-antagonists or beta-blokers, with significant renal or liver impairment, history of significant cardiovascular diseases, such as miocardial infarction or unstable angina. Patients without a caregiver.
    Pazienti attualmente in trattamento con calcio-antagonisti o betabloccanti, con insufficienza renale significativa, grave alterazione della funzione epatica, storia di malattie cardiovascolari significative tra cui recente infarto e angina pectoris instabile. Pazienti senza caregiver.
    E.5 End points
    E.5.1Primary end point(s)
    Change in cognitive function assessed with the ADAS-Cog 12 scale (Alzheimer's Disease Assessment Scale) and CDR-sb scale (Clinical Dementia Rating Scale sum of boxes)
    Cambiamento della funzione cognitiva valutata con la scala ADAS-Cog 12 (Alzheimer's Disease Assessment Scale) e se significativo la scala CDR-sb (Clinical Dementia Rating Scale sum of boxes) diverrà co-primario
    E.5.1.1Timepoint(s) of evaluation of this end point
    78 weeks
    78 settimane
    E.5.2Secondary end point(s)
    Change in the performance of activities of daily living assessed with the DAD scale
    Cambiamento nello svolgimento nelle attività della vita quotidiana valutate con la scala DAD (Disability Assessment for Dementia)
    E.5.2.1Timepoint(s) of evaluation of this end point
    78 weeks
    78 settimane
    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 No
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    nn
    nn
    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 Decision2013-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-16
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