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   43858   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:2012-000943-29
    Sponsor's Protocol Code Number:BP28248
    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:2012-10-09
    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 number2012-000943-29
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RO4602522 ADDED TO THE BACKGROUND THERAPY OF THE ACETYLCHOLINESTERASE INHIBITORS DONEPEZIL OR RIVASTIGMINE IN PATIENTS WITH MODERATE SEVERITY ALZHEIMER'S DISEASE
    STUDIO DI FASE II, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, A GRUPPI PARALLELI, CONTROLLATO CON PLACEBO, PER LA VALUTAZIONE DELL'EFFICACIA E DELLA SICUREZZA DI RO4602522 IN AGGIUNTA ALLA TERAPIA DI BASE CON L'INIBITORE DELL'ACETILCOLINESTERASI DONEPEZIL O RIVASTIGMINA IN PAZIENTI AFFETTI DA MALATTIA DI ALZHEIMER DI GRAVITA'MODERATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A CLINICAL STUDY TO INVESTIGATE THE EFFECTIVENESS AND SAFETY OF RO4602522 WHEN TAKEN IN ADDITION TO DONEPEZIL OR RIVASTIGMINE IN PATIENTS WITH MODERATE ALZHEIMERS DISEASE
    STUDIO CLINICO PER LA VALUTAZIONE DELL'EFFICACIA E LA SICUREZZA DI RO4602522 ASSUNTO IN COMBINAZIONE CON DONEPEZIL O RIVASTIGMINA IN PAZIENTI AFFETTI DA MALATTIA DI ALZHEIMER DI GRAVITÀ MODERATA
    A.4.1Sponsor's protocol code numberBP28248
    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 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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE SPA
    B.5.2Functional name of contact pointCOUNTRY HEAD CLIN. OPS. ITALY
    B.5.3 Address:
    B.5.3.1Street AddressVIALE G.B. STUCCHI 110
    B.5.3.2Town/ cityMONZA
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039 2475070
    B.5.5Fax number039 2475085
    B.5.6E-mailsergio.scaccabarozzi@roche.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 nameMAO-B Inhibitor
    D.3.2Product code Ro 460-2522/F02
    D.3.4Pharmaceutical form 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.3.9.1CAS number 676479-06-4
    D.3.9.2Current sponsor codeRO4602522
    D.3.9.3Other descriptive nameMAO-B inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.5
    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.3.1Product nameMAO-B Inhibitor
    D.3.2Product code Ro 460-2522/F03
    D.3.4Pharmaceutical form 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.3.9.1CAS number 676479-06-4
    D.3.9.2Current sponsor codeRO4602522
    D.3.9.3Other descriptive nameMAO-B inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboTablet
    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
    Alzheimer's Disease
    MALATTIA DI ALZHEIMER
    E.1.1.1Medical condition in easily understood language
    The most common form of dementia, i.e. the serious loss of global cognitive ability, beyond what might be expected from normal aging
    La più comune forma di demenza, ovvero la perdita grave di capacità cognitive generali, oltre quello che è atteso dal normale processo di invecchiamento
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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 efficacy of a 12-month treatment of RO4602522 versus placebo added to background therapy of donepezil or rivastigmine in patients with moderate severity AD MMSE 14-20 inclusive), based on mean change in ADAS Cog-11 scores cognitive endpoint) from baseline over time.
    L'obiettivo primario è la valutazione dell'efficacia di un trattamento di 12 mesi con RO4602522 rispetto a placebo in aggiunta alla terapia di base con donepezil o rivastigmina in pazienti affetti da malattia di Alzheimer di gravità moderata (punteggio MMSE tra 14 e 20 inclusi), in termini di variazione media dei punteggi ADAS-Cog-11 (endpoint cognitivo) dal basale nel corso del tempo.
    E.2.2Secondary objectives of the trial
    • Effect on cognition assessed with the ADAS-Cog-11 scale • Effect on functioning assessed with the ADCS-ADL scale • Effect on behavioral symptoms • Effect on the global measures assessed with the ADCS-CGIC scale and the Global Deterioration Scale (GDS). • Assessment of safety and tolerability • Estimating population-PK parameters and investigating the influence of various covariates on these parameters.
    -Effetto sulle capacità cognitive, valutato con la scala ADAS-Cog-11 -Effetto sulla funzionalità, valutato con la scala ADCS-ADL -Effetto sui sintomi comportamentali, valutato con le scale BEHAVE-AD-FW e AES -Effetto sui parametri globali, valutato con le scale ADCS-CGIC e GDS -valutare la sicurezza e la tollerabilità -stimare i parametri farmacocinetici della popolazione e investigare l'influenza di altre covariabili su questi parametri
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Probable AD, based on the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR criteria. 2. 50-90 years of age 3. MMSE score between 14 and 20 4. MRI supports a diagnosis of AD, with no evidence of other disease likely to account for the subject's dementia. 5. Body mass index (BMI) between 18 and 36. 6. Modified Hachinski Ischemia Score of ≤4. 7. Patients with CSDD scores ≤13. 8. Receiving treatment with donepezil or rivastigmine for at least 6 months prior to screening, with their dose and formulation stabilized at least 3 months prior to screening. 9. Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). 10. Have a caregiver who has frequent contact with the patient, who is considered reliable, who can accompany patient to study visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form.
    1.Malattia di Alzheimer probabile, in base ai criteri del NINCD/ADRDA (National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association, Istituto nazionale per i disturbi neurologici e della comunicazione e per l'ictus/Associazione per la malattia di Alzheimer e disturbi correlati) e del DSM-IV-TR. 2. Fascia di età: 50-90 anni di età, inclusi 3. Punteggio MMSE allo screening compreso tra 14 e 20, inclusi. 4. La lettura neuroradiologica centralizzata della RM allo screening supporta una diagnosi di malattia di Alzheimer, senza evidenza di altra malattia che potrebbe essere responsabile della demenza del soggetto o di criteri di esclusione in base alla RM 5.Indice di massa corporea (IMC) compreso tra 18 e 36 (inclusi) 6. Punteggio ischemico di Hachinski modificato &lt;=4. 7.Pazienti con punteggi CSDD (Cornell Scale for Depression in Dementia, Scala di Cornell per la depressione nella demenza) &lt;=13 8.Trattamento con donepezil o rivastigmina per almeno 6 mesi prima dello screening, con dose e formulazione stabili da almeno 3 mesi prima dello screening. 9.Buono stato di salute generale e in grado di deambulare o di deambulare con un ausilio (ovvero deambulatore o bastone). 10.Disponibilità di un caregiver o di qualche altra persona responsabile (ad es. familiare, operatore socio-assistenziale, assistente sociale o infermiere) che abbia un contatto frequente con il paziente (almeno 10 ore alla settimana), che sia considerato affidabile dallo sperimentatore nell’offrire assistenza al paziente per assicurare l'aderenza al trattamento dello studio, che possa accompagnare il paziente alle visite dello studio e assisterlo nelle procedure del protocollo e che sia inoltre in grado e dimostri volontà di fornire informazioni per la compilazione delle scale di valutazione del caregiver e di firmare il consenso informato del caregiver
    E.4Principal exclusion criteria
    1. Any neurological or psychiatric condition not specified in exceptions 2. Background of mental retardation 3. At risk of suicide 4. Uncontrolled behavioral symptoms 5. Alcohol and/or substance abuse or dependence in the past 2 years, except nicotine use 6. Preexisting neuropathy 7. Unstable or poorly controlled hypertension and/or cardiovascular disease 8. Clinically relevant ECG abnormality 9. Bradycardia 10. Aspartate aminotransferase, alanine aminotransferase or total bilirubin ≥1.5 times the upper limit of normal 11. HIV positive, history of Hepatitis B infection within the past year, or history of Hepatitis C infection 12. Hepatitis B virus surface Antigen (HBsAg) and/or Hepatitis C antibodies (HepCAb) positive 13. Abnormal thyroid function tests 14. Poorly controlled diabetes 15. Severe renal impairment 16. Requiring nursing home care 17. History of cancer except for localized, non-recurrent treated skin cancer and stabilized prostate adenocarcinoma 18. Involvement in any other investigational trial in the last 3 months 19. Current treatment for AD other than donepezil (5 mg/day to 10 mg/day) or rivastigmine (4.6 mg/24h or 9.5 mg/24h patch). Rivastigmine (oral formulations) is permitted up to 3 months prior to screening 20. Participation at any time in an active AD vaccine study 21. Participation in a passive AD immunization ≤ 1 year before screening 22. Recent (≤ 12 weeks) use of MAO inhibitors 23. Antidepressant treatment recently initiated (≤ 6 weeks). 24. Anti-psychotic use within 4 weeks before screening (except risperidone up to 1 mg/day, quetiapine up to 100 mg/day, olanzapine up to 5 mg / day) 25. Anxiolytics/ hypnotics use within 2 weeks before screening (except for benzodiazepines of short half-life for anxiety/sleeping disorders, if the patient is on stable dosage and regimen on them for at least 1 month prior to screening) 26. Anticonvulsant and anti-Parkinson's agents started within 2 weeks before screening 27. Anticholinergics/ antihistaminics started within 2 weeks before screening, except non-sedating antihistaminic medications 28. Recent (≤ 1 week) use of opioid drugs 29. Recent (≤ 1 week) use of cyclobenzaprine and dextromethorphan 30. Concomitant use of sympathomimetic drugs 31. Unwilling/ Unable to avoid ingesting food with high tyramine content (yeast concentrate, soy sauce, aged overripe cheese or very salty food)
    1.Qualsiasi condizione neurologica o psichiatrica non specificata nelle eccezioni. 2.Background di ritardo mentale. 3.Rischio di suicido 4.Sintomi comportamentali non controllati 5.Abuso o dipendenza da alcool e/o sostanze negli ultimi 2 anni, ad eccezione della nicotina il cui uso è ammesso. 6.Pazienti con neuropatia pre-esistente. 7.Ipertensione instabile o scarsamente controllata. 8.Pazienti con anomalia clinicamente rilevante su un elettrocardiogramma 9.Bradicardia 10.Aspartato aminotransferasi (AST), alanina aminotransferasi (ALT) o bilirubina totale a un valore ≥1,5 volte il limite superiore della norma 11.Sieropositività HIV accertata, anamnesi di infezione da epatite B nell'ultimo anno o anamnesi di infezione da epatite C. 12.Antigene di superficie del virus dell'epatite B (HBsAg) e/o anticorpi del virus dell'epatite C (HepCAb) positivi. 13.Test di funzionalità tiroidea anormali. 14.Diabete scarsamente controllato. 15.Grave compromissione della funzionalità renale. 16.Necessità di assistenza in una casa di cura. 17.Anamnesi di neoplasia, ad eccezione di casi localizzati, non ricorrenti, trattati di cancro della cute e adenocarcinoma prostatico stabilizzato. 18.Partecipazione a qualsiasi altra sperimentazione nei 3 mesi precedenti allo screening. 19.Trattamento in corso per la malattia di Alzheimer, diverso da donepezil (da 5 mg/giorno a 10 mg/giorno) o rivastigmina (cerotto da 4,6 mg/24 ore o 9,5 mg/24 ore). La rivastigmina (formulazioni orali) è ammessa fino a 3 mesi prima dello screening. 20.Partecipazione in qualsiasi momento a uno studio sul vaccino attivo conto la malattia di Alzheimer. 21.Partecipazione a uno studio di immunizzazione passiva contro la malattia di Alzheimer meno di 1 anno prima dello screening. 22.Uso recente (≤ 12 settimane) o concomitante di altri inibitori delle monoamminossidasi. 23.Non sono ammessi trattamenti antidepressivi iniziati di recente (≤ 6 settimane). 24.Non è ammesso l'uso di antipsicotici nelle 4 settimane precedenti allo screening, ad eccezione di risperidone fino a 1 mg/giorno, quetiapina fino a 100 mg/giorno, olanzapina fino a 5 mg/giorno. 25.Non è ammesso l'uso di ansiolitici/ipnotici nelle 2 settimane precedenti allo screening, ad eccezione delle benzodiazepine con emivita breve per l'ansia/disturbi del sonno, se il paziente è trattato con un regime e un dosaggio stabili da almeno 1 mese al momento dello screening. 26.Non è ammesso l'uso di anticonvulsivanti e farmaci anti-Parkinson nelle 2 settimane precedenti allo screening. 27.Non è ammesso l'uso di anticolinergici/antistaminici iniziati nelle 2 settimane precedenti allo screening. 28.Uso recente (meno di 1 settimana prima dello screening) o concomitante di farmaci oppioidi. 29.Uso recente (meno di 1 settimana prima dello screening) o concomitante di ciclobenzaprina e destrometorfano. 30.Uso concomitante di farmaci simpaticomimetici. 31.Mancata volontà o incapacità di evitare di consumare alimenti con elevato contenuto di tiramina, quali concentrato di lievito, salsa di soia, formaggio molto stagionato (odore forte, gusto pungente) o cibi molto salati.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline in ADAS-Cog-11 over 12 months.
    Variazione media dei punteggi ADAS-Cog-11 nel corso di 12 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    following 12-month treatment (compared to baseline)
    durante i 12 mesi di trattamento (rispetto al basale)
    E.5.2Secondary end point(s)
    The mean change from baseline over time in ADCS-ADL, BEHAVE AD-FW, AES, ADCS-CGIC and GDS scores, the proportion of patients worsening over time in BEHAVE-AD-FW and ADCS-CGIC scores, and time to change in GDS score by 1 point.
    variazione media nel tempo dei punteggi ADCS-ADL, BEHAVE AD-FW, AES, ADCS-CGIC e GDS; percentuale di pazienti in peggioramento per il punteggi BEHAVE-AD-FW e ADCS-CGIC; Tempo alla variazione di 1 punto del punteggio GDS
    E.5.2.1Timepoint(s) of evaluation of this end point
    following 12-month treatment (compared to baseline)
    durante i 12 mesi di trattamento (rispetto al basale)
    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 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
    Tolerability
    tollerabilità
    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.8.2.4Number of treatment arms in the trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Australia
    Canada
    United States
    E.8.7Trial has a data monitoring committee No
    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 end of the study will be considered to be the date of the last patient's last visit (LPLV), including the last follow-up visit.
    La fine dello studio è definita come l'ultima visita dell'ultimo paziente (LPLV), comprendendo anche l'ultima visita di follow-up
    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 months26
    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 months26
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 315
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Reduced decision-making capacity due to Alzheimer Disease
    Ridotta capacità decisionale dovuta alla malattia di Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 420
    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 study drug RO4602522 is for experimental use only and it will not yet be approved for use at the time of the completion of this study. There are other therapies available to treat Alzheimer's Disease. There are no plans for continued treatment with RO4602522 or medical supervision of the patients after the end of the trial. Decisions concerning the care of the patient will be left with the patients' treating physician after completion of the trial.
    il farmaco in studio RO4602522 è solo per uso sperimentale, è non sarà approvato alla commercializzazione al termine delo studio. Ci sono altre terapie disponibili per la malattia di Alzheimer. Al momento non ci sono programmi per la continuazione del trattamento con RO4602522 al termine dello studio. Sarà compito del medico curante decidere quali cure dare al paziente al completamento dello studio
    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 Decision2012-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-03
    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-Thu Apr 25 11:28:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA