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    Summary
    EudraCT Number:2010-021218-50
    Sponsor's Protocol Code Number:AB09004
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prohibited by CA
    Date on which this record was first entered in the EudraCT database:2011-10-07
    Trial 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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-021218-50
    A.3Full title of the trial
    A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease
    Multicentrická, dvojito zaslepená, placebom kontrolovaná, randomizovaná štúdia 3. fáze paralelných skupín pre vyhodnotenie bezpečnosti a účinnosti masitinibu pri liečbe pacientov s miernou až strednou formou Alzheimerovej choroby.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease
    Multicentrická, dvojito zaslepená, placebom kontrolovaná, randomizovaná štúdia 3. fáze paralelných skupín pre vyhodnotenie bezpečnosti a účinnosti masitinibu pri liečbe pacientov s miernou až strednou formou Alzheimerovej choroby.
    A.4.1Sponsor's protocol code numberAB09004
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportAB science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB science
    B.5.2Functional name of contact pointAlain Moussy
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number33147 20 23 11NA
    B.5.5Fax number33147 20 24 11NA
    B.5.6E-maila.moussy@abscience.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 namemastinib
    D.3.2Product code AB1010
    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 INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinb mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    mierna až stredná forma Alzheimerovej choroby
    E.1.1.1Medical condition in easily understood language
    mild to moderate Alzheimer’s disease
    mierna až stredná forma Alzheimerovej choroby
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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
    The objective is to compare the efficacy and safety of oral masitinib 3, 4,5 mg/kg/day or 4.5 mg/kg/day with a switch after 12 weeks of treatment to 6 mg/kg/day in combination with cholinesterase inhibitors and/or memantine to placebo in combination with cholinesterase inhibitors and/or memantine in patients with mild-to-moderate Alzheimer’s disease.

    • Co-Primary endpoints:
    - Effect on self-care and activities of daily living assessed by Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) at Week 24.
    - Effect on cognition and memory assessed by Alzheimer’s disease Assessment Scale (ADAS-Cog) from Week 8 to Week 24.

    The treatment effect needs to be established in at least one of the endpoints and both the endpoints will be simultaneously tested at 2.5% level of significance with a fallback procedure.

    Cieľom je porovnať účinnosť a bezpečnosť masitinibu podávaného orálne v dávke 3, 4,5 mg/kg/deň alebo 4,5 mg/kg/deň s prechodom na 6 mg/kg/deň po 12 týždňoch liečby v kombinácii s cholinesterázovými inhibítormi a/alebo memantinom k placebu v kombinácii s cholinesterázovými inhibítormi a /alebo memantinom u pacientov s miernou až strednou formou Alzheimerovej choroby
    Ko-primárne ciele:

    - Účinok na starostlivosti o seba a na aktivity denného života hodnotené za pomoci dotazníku Sebestačnosť v bežných denných činnostiach pre Alzheimerovu chorobu (ADCS-ADL) v týždni 24.
    - Účinok na kogníciu a pamäť zhodnotený Hodnotiacou škálou pre Alzheimerovu chorobu (ADAS-Cog) od týždňa 8 do týždňa 24.

    Liečebný účinok musí byť preukázaný aspoň v jednom koncovom bode a oba koncové body budú zároveň testované na 2,5% úrovni významnosti s fallback procedúrou.
    E.2.2Secondary objectives of the trial
    - Clinician’s Interview Based Impression of Change-plus (CIBIC-plus) at Week 24
    - Mini-Mental State Examination (MMSE) at Week 24
    - Clinical Dementia Rating (CDR) at Week 24
    - Neuropsychiatric Inventory (NPI) at Week 24
    - Clinical responder rate at Week 24
    - MRI assessment at Week 24
    - Safety: occurrence of Adverse Events (AE), changes on clinical examination including vital signs (blood pressure, pulse rate) and weight, ECG and laboratory exams (biochemistry, hematology and urinalysis)
    - Pharmacogenomic assessment: relationship between genomic data and safety
    - Pharmacokinetic (PK) analysis in some patients randomized in masitinib group


    - celkové hodnotenie pacienta lekárom pri zohľadnení názoru ošetrovateľa (CIBIC-plus) v týždni 24
    - orientačný diagnostický test Mini-Mental State Examination (MMSE) v týždni 24
    - klinické hodnotenie demencie (CDR) v týždni 24
    - neuropsychiatrický dotazník – Neuropsychiatric inventory (NPI) v týždni 24
    - počet pacientov, ktorí zodpovedajú klinicky v týždni 24
    - MRI hodnotenie v týždni 24.
    - bezpečnosť: výskyt nežiaducich príhod (Adverse events – AE), zmeny v klinických vyšetreniach vrátane vitálnych známok (krvný tlak, tepová frekvencia) a váha, EKG a laboratórne vyšetrenia (biochémia, hematológia a rozbor moči)
    - farmakogenomické vyhodnotenie: vzťah medzi genomickými dátami a bezpečnosťou
    - Farmakokinetická (PK) analýza u niektorých pacientov randomizovaných v skupine s masitinibom
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRI studies , pharmacokinetic study, pharmacogenomic study
    - a pharmacogenomic study in order to define efficacy or safety genomic predictive criteria.
    - MRIs studies: the first study is to define a new early marker of Alzheimer‘s disease ; the second is to quantify the amyloid load
    - a pharmacokinetic study, in up to 10 patients, to evaluate PK parameters of study treatment
    Farmakogenomické štúdie s cieľom stanoviť účinnosť alebo bezpečnosť genomické prediktívne kritériá.
    - MRIs štúdie: prvá štúdia bude definovať nový včasný ukazovateľ Alzheimerovej choroby; druhý bude kvantifikovať obsah amyloidu
    - Farmakokinetická štúdia u až 10 pacientov k evaluácii farmakokinetických parametrov študijnej liečby
    E.3Principal inclusion criteria
    1. Male or female patient
    2. Age ≥ 50 years, weight >50 kg with a Body Mass Index (BMI) >18 kg/m² at screening
    3. Patient and/ or caregiver able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment
    4. Menopause ≥ 2 years for female patient
    5. Patient with dementia of Alzheimer's type, according to DSM-IV criteria
    6. Patient with probable Alzheimer' disease according to NINCDS-ADRDA criteria
    7. Patient with MMSE ≥ 12 and ≤ 25 at baseline
    8. Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at baseline, with no changes foreseen in therapy throughout the study
    9. Patient with adequate organ function at screening and baseline:
    • Absolute Neutrophils Count (ANC) ≥ 2 x 109/L
    • Hemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 100 x 109/L
    • AST and ALT ≤ 3 ULN
    • Bilirubin ≤ 1.5 ULN
    • Albuminemia > 1 x LLN
    • Creatinine clearance > 60 mL/min calculated with both Cockcroft-Gault and MDDR (Modification of Diet in Renal Disease) formulae.
    • Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    10. Patient with a regular and reliable caregiver. The designated caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. The caregiver must have regular contact with the patient (i.e., an average of 10 or more hours per week), must be able to observe for possible adverse events, must be able to oversee patient’s compliance with the study treatment and to report on the patient’s status and must be able to accompany the patient to all visits
    11. Patient, identified caregiver and, if applicable, patient surrogate able and willing to comply with study visits and procedures per protocol, understand, sign, and date the informed consent form at screening visit prior to any protocol-specific procedures performed
    12. Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.
     Highly effective methods of contraception include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized male (azoospermia assessed medically)
    - Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
     Acceptable methods of contraception include:
    - Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    - Male or female condom with or without spermicide
    - Cap, diaphragm, or sponge with spermicide
    1. muž alebo žena
    2. vek ≥ 50 rokov, vážiaci viac nežs váhou ≥ 5049,9 kg a s Body Mass Indexom (BMI) >18 kg/m2 pri vstupnom vyšetrení (screening)
    3. pacienti a/alebo opatrovatelia schopní porozumieť karte pre pacientov a riadiť sa jej pokynmi v prípade výskytu symptómu (príznaku) závažnej neutropénie alebo závažnej kožnej toxicity, počas prvých dvoch mesiacov liečby.
    4. ženy ≥ 2 rokov po menopauze
    5. pacient s demenciou Alzheimerovho typu podľa kritérií DSM-IV
    6. pacienti pravdepodobne trpiaci Alzheimerovou chorobou podľa kritérií NINCDS-ADRDA
    7. MMSE ≥ 12 a ≤ 25 pri baseline
    8. pacienti, liečení minimálne 6 mesiacov stabilnými dávkami cholinesterázových inhibítorov (donepezil, rivastigmin nebo galantamin) na v dobe pred zahájením štúdie (baseline), a/alebo stabilnými dávkami memantinu po dobu minimálne 6 mesiacov v dobe pred zahájením štúdiena (baseline), bez predpokladaných zmien v terapii v priebehu tejto štúdie
    9. pacienti s dostatočnou funkciou orgánov pri screeningu a baseline:
    • celkový počet neutrofilov (ANC) ≥ 2 x 109/L
    • hemoglobín ≥ 10 g/dL
    • doštičky (PTL) ≥ 100 x 109/L
    • AST a /ALT ≤ 3 ULN
    • bilirubín ≤ 1.5 ULN
    • albuminémia >> 1 x LLN
    • klírens kreatinínu > 650 mL/min vypočítaný s Cockroft-Gaultovým a MDDR (Modification of Diet in Renal Disease) vzorcom.
    • proteinúria < 30 mg/dL (test prúžkom), v prípade proteinúrie ≥ 1+ na prúžku, 24 hodinová proteinúria musí byť ≤ 1,5g/24hodin
    10. pacienti so stálym a spoľahlivým opatrovateľom. Určený opatrovateľ musí dostatočne dobre poznať pacienta (rozhodnuté lekárom), aby mohol poskytnúť presné informácie. Opatrovateľ musí mať pravidelný kontakt s pacientom (tj. v priemere 10 a viac hodín týždenne), musí byť schopný rozpoznať prípadnú nežiaducu príhodu, dohliadnuť na dodržiavanie užívania študijnej medikácie pacientom, hlásiť pacientov stav a musí byť schopný odprevadiť pacienta na všetky študijné návštevy.
    11. pacienti, ich opatrovatelia, a príp. ich zástupcovia, schopní a ochotní dodržiavať plán študijných návštev a procedúry protokolu, ktorí porozumeli, podpísali a datovali formulár informovaného súhlasu pri screeningovej návšteve pred začatím akýchkoľvek procedúr súvisiacich s protokolom
    12. Pacienti mužského pohlavia s partnerkami v plodnom veku, ktorí súhlasia s používaním vysoko účinnej antikoncepcie a akceptovateľnej metódy antikoncepcie ich partnerkami počas štúdie a po 3 mesiace po poslednom užití študijnej liečby.
    • Vysoko účinné metódy antikoncepcie zahŕňajú:
     Kombinovaná hormonálna antikoncepcia (obsahujúca estrogén alebo gestagén) spojená s potlačením ovulácie: orálna, intravaginálna alebo transdermálna.
     Hormonálna antikoncepcia obsahujúca len gestagén spojená s potlačením ovulácie: orálna, injekčná alebo implantačná.
     Vnútromaternicové teliesko.
     Vnútromaternicový systém.
     Obojstranné podviazanie vajcovodov.
     Vazektómia muža (medicínsky hodnotená azoospermia).
     Sexuálna abstinencia (jej spoľahlivosť by mala byť hodnotená vo vzťahu k trvaniu klinického skúšania a preferovanému a obvyklému životnému štýlu pacienta).

    • Prijateľné metódy antikoncepcie zahŕňajú:
     Hormonálna antikoncepcia obsahujúca gestagén, kde potlačenie ovulácie nie je primárnym spôsobom účinku.
     Mužský alebo ženský kondóm s/bez spermicídu.
     Diafragma, cervikálny klobúčik alebo antikoncepčná špongia
    E.4Principal exclusion criteria
    1. Patient with any other cause of dementia not due to Alzheimer's disease. If a specific examination including a brain neuro-imagery exam had been performed within the last 6 months that shows the following, the patient cannot be enrolled::
    • Other central nervous condition causing progressive deficits in memory and cognition, e.g. cerebrovascular disease (patient with not more than 4 microbleeds and not more than 2 lacunes at the MRI could be enrolled in the study), Parkinson's disease, Huntington's disease, brain tumor…
    • Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection…
    • Substance-induced dementia
    2. Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms of delusions and delirium will be allowed in the study)
    3. Patient treated with any registered or putative cognitive/memory enhancer or disease modifier other than donepezil, galantamine, rivastigmine or memantine. (Patient taking Ginkgo Biloba can be enrolled providing it has been taken at a stable dose for at least 6 months).
    4. Patient with evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychiatric disorder
    5. Patient with active current bacterial (including tuberculosis), viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster), fungal, mycobacterium, protozoan, or other infection
    6. Patient with history of infection requiring hospitalization within 2 weeks of screening
    7. Patient presenting with cardiac disorders defined by at least one of the following conditions:
    • Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    • Patient with cardiac failure class III or IV of the NYHA classification
    • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    • Syncope without known aetiology within 3 months
    • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    8. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
    9. Patient with life expectancy < 1 year
    Previous medications:
    10. Patient treated with any investigational agent within 4 weeks of screening
    1. pacienti s demenciou spôsobenou akoukoľvek inou príčinou než je Alzheimerova choroba. Pokiaľ bolo vykonané špecifické vyšetrenie zahrňujúce zobrazovaciu metódu mozgu behom posledných 6 mesiacov a ktoré ukazuje jedno z nasledujúcich, pacient nemôže byť zaradený:
    • iné postihnutie centrálneho nervového systému spôsobujúce progresívny deficit pamäti a stratu kognitívnych schopností napr. cievna mozgová choroba (pacient s nie viac ako 4 mikro krvácaniami a nie viac ako 2 lakúnami na MRI môžu byť zaradení do štúdie), Parkinsonova choroba, Huntingtonova choroba, mozgový tumor…
    • systémové postihnutie spôsobujúce demenciu napr. hypotyroidizmus, neliečený deficit vitamínu B12 alebo kyseliny listovej, nedostatok niacínu, neurosyfilis, infekcia HIV…
    • demencia spôsobená cudzími látkami
    2. pacienti s Alzheimerovou chorobou trpiaci závažnou formou bludov alebo v delíriu (pacienti s ľahkou a miernou formou bludov a delírií budú povolení v štúdií)
    3. pacienti liečení registrovanými alebo domnelými liekmi zlepšujúcimi kognitívne schopnosti alebo upravujúce stav choroby, inými ako donepezil, galantamin, rivastigmin alebo memantin (pacienti užívajúci ginkgo biloba môžu byť zaradení v prípade, že ho preukázateľne užívali v stabilných dávkach po dobu najmenej 6 mesiacov)
    4. pacienti so známkami psychózy a/alebo užívajúci antipsychotiká v dobe screeningu alebo s anamnézou závažných psychických porúch
    5. pacienti s akútnou bakteriálnou (vrátane tuberkulózy), vírovou (vrátane hepatitídy B a C, HIV, EBV, CMV, herpes zoster), plesňovou, mykobakteriálnou, protozoálnou alebo inou infekciou
    6. pacienti s anamnézou infekcie vyžadujúci hospitalizáciu behom 2 týždňov od screeningu
    7. pacienti trpiaci srdcovou poruchou, definovanou aspoň jednou z nasledujúcich podmienok:
    • pacienti s nedávnou srdcovou príhodou (behom uplynulých 6 mesiacov):
    - akútny koronárny syndróm
    - akútne zlyhanie srdca (stupeň III alebo IV podľa klasifikácie NYHA)
    - významná komorová arytmia (pretrvávajúca komorová tachykardia, ventrikulárna fibrilácia, resuscitovaná náhla smrť)
    • pacienti so zlyhaním srdca III. alebo IV. stupňa klasifikácie NYHA
    • pacienti so závažnými poruchami vodivosti, ktoré nie sú riešené permanentným pacingom (atrioventrikulárna blokáda 2. a 3. stupňa, sino-atriálna blokáda)
    • synkopy neznámeho pôvodu behom 3 mesiacov
    • nekontrolovaná ťažká hypertenzia, podľa posúdenia skúšajúceho, alebo symptomatická hypertenzia
    8. pacienti so záznamami zlej spolupráce alebo anamnézou zneužívania drog/alkoholu, alebo nadmernej konzumácie alkoholických nápojov, ktorá by mohla negatívne ovplyvniť ich schopnosť dodržiavať pokyny v protokole, alebo pacienti s prebiehajúcim alebo prekonaným psychiatrickým ochorením, ktoré by mohlo negatívne ovplyvniť schopnosť dodržiavať pokyny protokolu štúdie alebo dať informovaný súhlas
    9. Pacienti s očakávanou dobou života < 1 rok

    PREDCHÁDZAJÚCA LIEČBA:
    10. Pacienti liečení akýmkoľvek skúšobným liekom v priebehu 4 týždňov pred screeningom
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary endpoints:
    --Effect on self-care and activities of daily living assessed by Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) at Week 24.
    --Effect on cognition and memory assessed by Alzheimer’s disease Assessment Scale (ADAS-Cog) from Week 8 to Week 24.
    Ko-primárne ciele:

    - Účinok na starostlivosti o seba a na aktivity denného života hodnotené za pomoci dotazníku Sebestačnosť v bežných denných činnostiach pre Alzheimerovu chorobu (ADCS-ADL) v týždni 24.
    - Účinok na kogníciu a pamäť zhodnotený Hodnotiacou škálou pre Alzheimerovu chorobu (ADAS-Cog) od týždňa 8 do týždňa 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    týžden 24
    E.5.2Secondary end point(s)
    - Clinician’s Interview Based Impression of Change-plus (CIBIC-plus) at Week 24
    - Mini-Mental State Examination (MMSE) at Week 24
    - Clinical Dementia Rating (CDR) at Week 24
    - Neuropsychiatric Inventory (NPI) at Week 24
    - Clinical responder rate at Week 24
    - MRI assessment at Week 24
    - Safety: occurrence of Adverse Events (AE), changes on clinical examination including vital signs (blood pressure, pulse rate) and weight, ECG and laboratory exams (biochemistry, hematology and urinalysis)
    - Pharmacogenomic assessment: relationship between genomic data and safety
    - Pharmacokinetic (PK) analysis in some patients randomized in masitinib group
    - celkové hodnotenie pacienta lekárom pri zohľadnení názoru ošetrovateľa (CIBIC-plus) v týždni 24
    - orientačný diagnostický test Mini-Mental State Examination (MMSE) v týždni 24
    - klinické hodnotenie demencie (CDR) v týždni 24
    - neuropsychiatrický dotazník – Neuropsychiatric inventory (NPI) v týždni 24
    - počet pacientov, ktorí zodpovedajú klinicky v týždni 24
    - MRI hodnotenie v týždni 24.
    - bezpečnosť: výskyt nežiaducich príhod (Adverse events – AE), zmeny v klinických vyšetreniach vrátane vitálnych známok (krvný tlak, tepová frekvencia) a váha, EKG a laboratórne vyšetrenia (biochémia, hematológia a rozbor moči)
    - farmakogenomické vyhodnotenie: vzťah medzi genomickými dátami a bezpečnosťou
    - Farmakokinetická (PK) analýza u niektorých pacientov randomizovaných v skupine s masitinibom
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    týžden 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 trial5
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Czech Republic
    France
    Germany
    Poland
    Romania
    Serbia
    Singapore
    Slovakia
    South Africa
    Spain
    Taiwan
    Tunisia
    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
    Not applicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 675
    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)
    Patients will be treated according to the current standard of care in their country.
    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 Decision2011-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-05
    P. End of Trial
    P.End of Trial StatusProhibited by CA
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