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    Summary
    EudraCT Number:2012-003111-58
    Sponsor's Protocol Code Number:AD-4833/TOMM40_301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-25
    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 number2012-003111-58
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI due to AD in Cognitively Normal Subjects
    Studio in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli per qualificare simultaneamente un algoritmo basato su biomarcatori per la prognosi del rischio di sviluppare deterioramento cognitivo lieve (Mild Cognitive Impairment, MCI) dovuto alla Malattia di Alzheimer (Alzheimer’s Disease, AD) (MCI dovuto ad AD) e testare la sicurezza e l’efficacia di pioglitazone (AD-4833 SR 0,8 mg QD) al fine di ritardare l’insorgenza di MCI dovuto ad AD in soggetti cognitivamente normali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying its Onset
    Qualificazione di un algoritmo basato su biomarcatori sul rischio di deterioramento cognitivo lieve dovuto a Malattia di Alzheimer e valutazione della sicurezza e della efficacia di pioglitazone nel ritardare la sua comparsa
    A.4.1Sponsor's protocol code numberAD-4833/TOMM40_301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01931566
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1139-0355
    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 SponsorTakeda Development Centre Europe Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Centre Europe Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440203116 8000
    B.5.5Fax number440203116 8199
    B.5.6E-mailclinicaloperations@tgrd.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 namepioglitazone sustained-release
    D.3.2Product code AD-4833 SR
    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.3.8INN - Proposed INNpioglitazone
    D.3.9.1CAS number 112529-15-4
    D.3.9.2Current sponsor codeAD-4833
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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
    Mild cognitive impairment due to Alzheimer’s disease
    deterioramento cognitivo lieve dovuto alla Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Mild cognitive impairment due to Alzheimer’s disease
    deterioramento cognitivo lieve dovuto alla Malattia di Alzheimer
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    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
    For biomarker risk algorithm qualification:
    -To qualify the biomarker risk algorithm composed of TOMM40 rs10524523 genotype, APOE genotype, and age for prognosis of the risk of developing MCI due to AD within 5 years.

    For efficacy evaluation of pioglitazone:
    - To evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI due to AD in cognitively-normal subjects who are at high-risk, as identified by the biomarker risk algorithm at enrollment, for
    developing MCI due to AD within 5 years.
    Per la qualificazione dell’algoritmo basato su biomarcatori di rischio:
    -qualificare l’algoritmo basato su biomarcatore di rischio costituiti da genotipo TOMM40 rs10524523, genotipo APOE ed età per la prognosi del rischio di sviluppare MCI dovuto ad AD entro 5 anni.
    Per la valutazione dell’efficacia di pioglitazone:
    -valutare l’efficacia di pioglitazone rispetto al placebo per ritardare l’insorgenza di MCI dovuto ad AD in soggetti cognitivamente normali che sono ad alto rischio, come identificato dall’algoritmo di biomarcatore di rischio all’arruolamento, di sviluppare MCI dovuto ad AD entro 5 anni.
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of pioglitazone compared with placebo on the progression of cognitive decline.
    -To evaluate the effect of pioglitazone compared with placebo on functional decline and instrumental activities of daily living.

    -Valutare l’effetto di pioglitazone rispetto al placebo sulla progressione del declino cognitivo.
    -Valutare l’effetto di pioglitazone rispetto al placebo sul declino funzionale e le attività strumentali della vita quotidiana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or postmenopausal female subject between 65 and 83 years of age, inclusive at the time of the screening visit.
    2. The subject must be cognitively normal at baseline, scoring as indicated for the following tests:
    - Clinical Dementia Rating (CDR)=0.
    - At least one memory test above -1.5 SD of the demographically corrected normative mean.
    3. The subject must score ≥25 on the Mini Mental Status Examination (MMSE) at the screening visit after the education and age adjustment referenced in Appendix G of the protocol.
    4. All subjects require a project partner who can separately complete an Acknowledgment Form on his/her own behalf and take part in the study to provide information on the cognitive, functional, and behavioral status of the subject and to assist with monitoring of study medication, if needed.
    5. The subject has the ability and intention to participate in regular study visits, in the opinion of the Investigator.
    1.Soggetti di sesso maschile o femminile in postmenopausa di età compresa tra 65 e 83 anni, inclusi al momento della visita di screening.
    2.Il soggetto deve essere cognitivamente normale al basale, con un punteggio come indicato per i seguenti test:
    -Scala per la valutazione clinica della demenza (Clinical Dementia Rating, CDR)=0.
    -Almeno un test di memoria superiore a -1,5 SD rispetto alla media normativa demograficamente corretta.
    3.Il soggetto deve presentare un punteggio ≥25 secondo il Mini Esame dello Stato Mentale (Mini Mental Status Examination, MMSE) alla visita di screening successivamente all’aggiustamento in base all’istruzione e classe di età indicato nell’Appendice G.
    4.Tutti i soggetti necessitano di un/a compagno/a per il progetto che possa compilare separatamente un Modulo di attestazione per proprio conto e prendere parte allo studio per fornire informazioni sullo stato cognitivo, funzionale e comportamentale del soggetto e che assista con il monitoraggio del farmaco dello studio, se necessario.
    5.Il soggetto ha la capacità e l’intenzione di partecipare alle visite dello studio regolarmente, secondo il parere dello sperimentatore.
    E.4Principal exclusion criteria
    1. The subject has a current diagnosis or history of any type of cognitive impairment or dementia, or has a current diagnosis or history of neurological/psychiatric disorder or any other diagnosis that significantly affects cognitive performance (eg, mental retardation, organic mental disorder).
    2. The subject has a current diagnosis of significant psychiatric illness, per the Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) (including but not limited to major depressive disorder, anxiety disorders) and is in an acute phase/episode, or the subject has a current diagnosis or history of schizophrenia or bipolar disorder.
    3. The subject has glycosylated hemoglobin (HbA1c) >8.0% at the time of baseline or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor-gamma agonist.
    The subject should be on a stable antidiabetic regimen for at least 3 months prior to enrollment.
    4. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. History of HIV infection is considered exclusionary for this study.
    5.The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse/dependence within 2 years prior to the Screening Visit.
    6.The subject has a history or current diagnosis of macular edema or macular degeneration.
    7. If female, the subject has a history of postmenopausal fractures with no or minimal trauma (eg, wrist, hip, lumbar or thoracic vertebral fracture).
    8. The subject has a history or current diagnosis of congestive heart failure (CHF), New York Heart Association Class III-IV.
    9. The subject has been exposed to cognitive tests performed in this study within 6 months prior to the Screening Visit with the exception of the MMSE.
    10. The subject’s TOMM40 rs10524523 or APOE genotypes or APOE phenotype are known by the subject or the study staff participating in this study.
    1.Il soggetto presenta una diagnosi attuale o una anamnesi di qualsiasi tipo di deterioramento cognitivo o demenza, o presenta una diagnosi attuale o una anamnesi di disturbo neurologico/psichiatrico o qualsiasi altra diagnosi che influisca significativamente sulle prestazioni cognitive (ad es., ritardo mentale, disturbo mentale organico).
    2.Il soggetto presenta una diagnosi attuale di malattia psichiatrica significativa, in base al Manuale Diagnostico e Statistico dei Disturbi Mentali (Diagnostic & Statistical Manual of Mental Disorders), 4a Edizione - Revisione del testo (DSM-IV-TR) (inclusi, ma in via non limitativa, disturbo depressivo maggiore, disturbi d’ansia) e si trova in una fase/episodio acuti, o il soggetto presenta una diagnosi attuale o un’anamnesi di schizofrenia o disturbo bipolare.
    3.Il soggetto ha un livello di emoglobina glicosilata (HbA1c) >8,0% al basale o necessita di trattamento con insulina, terapia antidiabetica orale tripla o un agonista del recettore attivato dai proliferatori dei perossisomi (peroxisome proliferator-activated receptor, PPARī§). Il soggetto deve aver seguito un regime antidiabetico stabile per almeno 3 mesi prima dell’arruolamento.
    4.Il soggetto è affetto da una malattia instabile clinicamente significativa, per esempio, insufficienza epatica o insufficienza renale, o disturbi cardiovascolari, polmonari, gastrointestinali (incluso bypass gastrico post-chirurgico), endocrini, neurologici, reumatologici, immunologici, infettivi, cutanei e dei tessuti sottocutanei o disturbo metabolico. Un’anamnesi di infezione da HIV determina l’esclusione da questo studio.
    5.Il soggetto presenta un’anamnesi di abuso di droghe (definito come uso di droghe illecite) o un’anamnesi di abuso/dipendenza da alcool nei 2 anni precedenti la visita di screening.
    6.Il soggetto presenta un’anamnesi o una diagnosi attuale di edema maculare, degenerazione o qualsiasi maculopatia.
    7.Se di sesso femminile, il soggetto presenta un’anamnesi di fratture postmenopausali con trauma minimo o assente (ad es., frattura del polso, dell’anca, lombare o toracica vertebrale).
    8.Il soggetto presenta un’anamnesi o diagnosi attuale di insufficienza cardiaca congestizia (Congestive Heart Failure, CHF), di classe III-IV in base alla New York Heart Association (NYHA).
    9.Il soggetto è stato esposto a test cognitivi effettuati in questo studio nei 6 mesi precedenti la visita di screening ad eccezione dell’MMSE.
    10.I genotipi TOMM40 rs10524523 o APOE o il fenotipo APOE del soggetto sono noti al soggetto o al personale dello studio che partecipano a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    For biomarker risk algorithm qualification:
    -Time to diagnosis of MCI due to AD for placebo-treated, high-risk, non-Hispanic/Latino Caucasian subjects versus placebo-treated, low-risk, non-Hispanic/Latino Caucasian subjects.

    For efficacy evaluation of pioglitazone:
    Time to diagnosis of MCI due to AD for pioglitazone-treated, non-Hispanic/Latino Caucasian subjects versus placebo-treated non-Hispanic/Latino, Caucasian subjects in the high-risk stratum.
    Endpoint primario per la qualificazione dell’algoritmo basato su biomarcatori di rischio:
    •Il tempo alla diagnosi di MCI dovuto ad AD per soggetti caucasici non ispanico/latini ad alto rischio, trattati con placebo rispetto a soggetti caucasici non ispanico/latini a basso rischio trattati con placebo.

    L’endpoint primario per la valutazione di efficacia di pioglitazone:
    •Il tempo alla diagnosi di MCI dovuto ad AD per soggetti caucasici non ispanico/latini trattati con pioglitazone rispetto a soggetti caucasici non ispanico/latini trattati con placebo nel gruppo ad alto rischio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    MCI event could occur at any time during the study, so there is no fixed timepoint for evaluation of an individual event.
    episodio/i di MCI potranno avvenire in ogni momento dello studio, quindi non c’è un tempo stabilito di rilevazione di un singolo evento.
    E.5.2Secondary end point(s)
    -Change from baseline for cognitive decline on composite score on the cognitive battery for pioglitazone-treated subjects versus placebo-treated subjects in the high-risk stratum.

    - Changes from baseline in instrumental activities of daily living (Alzheimer’s Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) between pioglitazone-treated and placebo-treated groups of the high-risk stratum.
    •Variazione dal basale per declino cognitivo su punteggio composito sulla batteria cognitiva per i soggetti trattati con pioglitazone rispetto ai soggetti trattati con placebo nello strato ad alto rischio.
    •Variazioni dal basale nelle attività strumentali della vita quotidiana (Studio Cooperativo sulla Malattia di Alzheimer Attività della Vita Quotidiana - Strumento di prevenzione [Alzheimer’s Disease Cooperative Study Activities of Daily Living - Prevention Instrument, ADCS ADL-PI]) tra gruppi trattati con pioglitazone e gruppi trattati con placebo dello strato ad alto rischio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline to event which could occur at any time during the study.
    Cambiamento rispetto al basale per evento/i che possono avvenire in qualunque momento durante lo studio.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarker risk algorithm qualification
    qualificazione di un algoritmo basato su biomarcatori di rischio
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Germany
    Italy
    Russian Federation
    Switzerland
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5800
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2100
    F.4.2.2In the whole clinical trial 5800
    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 subject should be returned to the care of a physician and standard therapies as required.
    I soggetti torneranno in base alle proprio necessità alle cure del proprio medico e al trattamento standard.
    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 Decision2015-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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