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    Summary
    EudraCT Number:2013-000001-23
    Sponsor's Protocol Code Number:14861B
    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:2014-04-15
    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 number2013-000001-23
    A.3Full title of the trial
    An open-label extension study to evaluate the long-term
    safety and tolerability of Lu AE58054 as adjunctive
    treatment to donepezil in patients with mild-moderate
    Alzheimer's disease
    Studio di estensione in aperto per valutare la sicurezza e la tollerabilità a lungo termine di Lu AE58054 come trattamento aggiuntivo a donepezil in pazienti affetti da malattia di Alzheimer da lieve a moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety and Tolerability of Lu AE58054 as Adjunctive Treatment to donepezil in Patients With Mild-moderate Alzheimer's Disease
    Sicurezza e tollerabilità a lungo termine di Lu AE58054 come terapia aggiuntiva a donepezil in pazienti affetti da malattia di Alzheimer da lieve a moderata
    A.4.1Sponsor's protocol code number14861B
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH- Lundbeck A/S
    B.5.2Functional name of contact pointlundbeckclinicaltrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby, Copenhagen
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.6E-maillundbeckclinicaltrials@lundbeck.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 nameLu AE58054
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot available
    D.3.9.2Current sponsor codeLu AE58054
    D.3.9.4EV Substance CodeSUB114522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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 Lu AE58054
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot available
    D.3.9.2Current sponsor codeLu AE58054
    D.3.9.4EV Substance CodeSUB114522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer´s disease
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer´s disease
    Malattia di Alzheimer
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    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 Lu AE58054 as adjunctive therapy to donepezil in patients with mild-moderate AD.
    Valutare la sicurezza e la tollerabilità a lungo termine di Lu AE58054 come terapia aggiuntiva a donepezil in pazienti affetti da malattia di Alzheimer da lieve a moderata.
    E.2.2Secondary objectives of the trial
    To evaluate the disease development during long-term treatment with Lu AE58054 as adjunctive therapy to donepezil.
    Valutare lo sviluppo della malattia durante il trattamento a lungo termine con Lu AE58054 come terapia aggiuntiva a donepezil.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A or 14862A.
    • Il paziente ha completato la visita 7 (visita di conclusione) degli studi clinici lead-in, in doppio cieco, controllati contro placebo, 14861A o 14862A.
    E.4Principal exclusion criteria
    • The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
    • The patient has experienced seizures before Completion Visit in the lead-in study.
    • The patient has evidence of clinically significant disease.
    • The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
    • The patient is receiving therapy with another AChEI or memantine.
    • Il paziente manifesta un evento avverso in corso, moderato o grave, insorto durante lo studio lead-in, che lo sperimentatore considera essere un rischio potenziale per la sicurezza.
    • Il paziente ha sperimentato convulsioni prima della Visita di Conclusione dello studio lead-in.
    • Il paziente ha evidenza di malattia clinicamente significativa.
    • Il trattamento con donepezil del paziente rischia di essere interrotto o è interrotto durante lo studio.
    • Il paziente è in terapia con un altro AChEI e/o memantina.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety: Number of adverse events
    • Tolerability: Number of withdrawals
    - Sicurezza: numero di eventi avversi
    - Tollerabilità: numero di ritiri
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 weeks and a 4-week safety follow-up
    fino a 28 settimane e al follow-up di sicurezza a 4 settimane
    E.5.2Secondary end point(s)
    • Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score
    • Change in global impression: Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score
    • Change in functioning: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score
    • Change in behavioural disturbance: Change in Neuropsychiatric Inventory (NPI) total score
    • Change in cognitive aspects of mental function: Change in Mini Mental State Examination (MMSE)
    • Risk of Suicidality Using C-SSRS Scores: Columbia Suicide Severity Rating Scale (C-SSRS)
    - Variazione delle capacità cognitive: Variazione del punteggio totale della sottoscala cognitiva ADAS-Cog (Alzheimer's Disease Assessment Scale cognitive subscale)
    - Variazione impressione globale: Punteggio della scala ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change)
    - Variazione di funzionamento: Variazione del punteggio totale della scala ADCS-ADL23 (Alzheimer's Disease Cooperative Study - - Variazione disturbi comportamentali: Variazione del punteggio totale del Neuropsychiatric Inventory (NPI)
    - Variazione aspetti cognitivi della funzione mentale: Variazione del Mini Mental State Examination (MMSE)
    - rischio di suicidio utilizzando i punteggi C-SSRS: Columbia Suicide Severity Rating Scale (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 28 for all, except for Risk of Suicidality which is up to week 28.
    basale e settimana 28 per tutti, ad eccezione del rischio di suicidio, per cui è sino a settimana 28
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial1
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA108
    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
    Belgium
    Bulgaria
    Canada
    Denmark
    France
    Ireland
    Italy
    Croatia
    Portugal
    Romania
    Argentina
    Brazil
    Chile
    Czech Republic
    Estonia
    Finland
    Germany
    Korea, Republic of
    Lithuania
    Spain
    Israel
    Poland
    South Africa
    Taiwan
    Ukraine
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days9
    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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1505
    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
    Soggetti affetti da malattia di Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 802
    F.4.2.2In the whole clinical trial 1770
    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)
    The 28 week treatment period will be followed by a 4 week safety follow up period without treatment with IMP
    Il periodo di trattamento di 28 settimane è seguito da un periodo di follow-up di 4 settimane senza trattamento con IMP.
    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 Decision2014-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
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