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    Summary
    EudraCT Number:2013-000307-17
    Sponsor's Protocol Code Number:DIAN-TU-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000307-17
    A.3Full title of the trial
    A Phase II/III randomized, double-blind, placebo-controlled multi-center study of 2 potential disease modifying therapies in individuals at risk for and with dominantly inherited Alzheimer's disease (ADAD)
    Studio di fase II/III, randomizzato, in doppio cieco, controllato con placebo, multicentrico, per la valutazione di 2 terapie potenziali modificanti la malattia in individui a rischio di e affetti da malattia di Alzheimer autosomica dominante (Autosomal Dominant Alzheimer’s Disease, ADAD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation
    Studio sulla Rete per la malattia di Alzheimer autosomica dominante: un'opportunità per prevenire la demenza. Uno studio con trattamenti potenzialmente modificanti la malattia in gli individui a rischio o con un tipo di malattia di Alzheimer ad insorgenza precoce causata da una mutazione genetica
    A.4.1Sponsor's protocol code numberDIAN-TU-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01760005
    A.5.4Other Identifiers
    Name:The Alzheimer's Association Grant Number:DIAN TTU-12-243040
    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 SponsorWashington University in St. Louis
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHoffman LaRoche; Eli Lilly; The Alzheimer's Association; AVID Radio Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWashington University in St. Louis
    B.5.2Functional name of contact pointSusan Mills, Sr. Project Manager
    B.5.3 Address:
    B.5.3.1Street Address4488 Forest Park Ave., Suite 301,
    B.5.3.2Town/ citySt Louis
    B.5.3.3Post codeMO 63108
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-949-293-5290
    B.5.5Fax number1-314-747-7060
    B.5.6E-mailmillss@neuro.wustl.edu
    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 nameSolanezumab
    D.3.2Product code LY2062430
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolanezumab
    D.3.9.1CAS number 955085-14-0
    D.3.9.2Current sponsor codeLY2062430
    D.3.9.3Other descriptive nameSOLANEZUMAB
    D.3.9.4EV Substance CodeSUB37126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameGantenerumab
    D.3.2Product code RO4909832
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGantenerumab
    D.3.9.1CAS number 645-35-2
    D.3.9.2Current sponsor codero4909832
    D.3.9.3Other descriptive nameHISTIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14110MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Amyvid
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Grootslag 1‑5, NL‑3991 RA - Houten, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFlorbetapir (18F)
    D.3.2Product code Florbetapir (18F)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlorbetapir (18F)
    D.3.9.3Other descriptive nameFLORBETAPIR F18
    D.3.9.4EV Substance CodeSUB31310
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number720 to 2090
    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 Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autosomal Dominant Alzheimer's disease
    Malattia di Alzheimer autosomica dominante
    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 16.0
    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
    1. Assess safety and tolerability of gantenerumab and solanezumab in individuals who have mutations causing dominantly inherited Alzheimer’s disease.
    2. Assess biological efficacy/target engagement of gantenerumab and solanezumab in individuals who have mutations causing dominantly inherited Alzheimer’s disease as measured by the primary biomarker measure for each drug. Primary endpoints are specified for each drug based on mechanism of action. Depending on proposed mechanism of action, the primary biomarker endpoint will be either 1) change in amyloid deposition as measured by [11C]PiB-PET composite standardized uptake value ratio (C-SUVR, average of precuneus, caudate, gyrus rectus, occipital cortex, parietal cortex, prefrontal cortex and temporal cortex) or, 2) changes in free and total amyloid beta (Aβ) isoforms in CSF.
    1. Valutazione della sicurezza e della tollerabilità di gantenerumab e solanezumab in individui portatori di mutazione che causa la malattia di Alzheimer autosomica dominante. 2. Valutazione dell'efficacia biologica/interazione con il bersaglio di gantenerumab e solanezumab in individui portatori di mutazione che causa la malattia di Alzheimer autosomica dominante in base alla misurazione degli endpoint primari (biomarcatori) per ciascun farmaco. Gli endpoint primari sono specificati per ogni farmaco in base al meccanismo d'azione. A seconda del meccanismo d'azione proposto, l'endpoint primario (biomarcatore) sarà 1) la variazione del deposito di amiloide misurata mediante il rapporto del valore di composite standardized uptake, C-SUVR con [11C]PiB-PET (C-SUVR, media di precuneo, caudato, giro retto, corteccia occipitale, corteccia parietale, corteccia prefrontale e corteccia temporale) o 2) variazioni delle isoforme libere e totali di Aβ nel CSF.
    E.2.2Secondary objectives of the trial
    Secondary study endpoints will include:
    1) Change in amyloid deposition as measured by [11C]PiB-PET C-SUVR (used as a secondary outcome measure when not the primary outcome measure).
    2) Change in CSF amyloid-beta peptide concentrations (used as a secondary outcome measure when not the primary outcome measure).
    3) Change of CSF biomarkers tau and ptau181 values compared between subjects on active drug (gantenerumab or solanezumab) and mutation carriers in the pooled placebo group.
    4) Rate of brain atrophy in treatment groups vs. pooled placebo group as measured by cortical thickness of regions of interest (volumetric MRI).
    5) Change in FDG-PET metabolism in specific regions of interest in treated group as compared to pooled placebo group.
    6) Exploratory cognitive and behavioral outcome measures
    7) Exploratory imaging measures
    8) Assess longitudinal change in biomarker and cognitive measures in individuals who do not have mutations causing dominantly inherited Alzheimer’s disease
    •Variazione del deposito di amiloide misurata mediante il SUVR composito con [11C]-PiB-PET •Variazione delle concentrazioni di peptide Abeta nel CSF •Variazione dei valori dei biomarcatori tau e ptau181 nel liquido cerebrospinale confrontata tra i soggetti trattati con farmaco attivo e i portatori della mutazione nel gruppo placebo raggruppato. •Tasso di atrofia cerebrale nei gruppi di trattamento attivo rispetto al gruppo placebo raggruppato, misurato mediante lo spessore corticale delle regioni di interesse (RM volum).•Variazione del metabolismo con FDG-PET in regioni di interesse specifiche (ad es. precuneo) nel gruppo trattato con farmaco attivo rispetto al gruppo placebo raggruppato. •Parametri degli esiti esplorativi cognitivi e comportamentali •Parametri esplorativi di imaging
    •Valutazione della variazione longitudinale dei parametri costituiti da biomarcatori e funzionalità cognitive in individui non portatori di mutazione che causa ADAD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet ALL inclusion criteria:

    1.Know they have an AD-causing mutation or be unaware of their genetic status and have a 50% chance of having an AD-causing mutation (e.g. parent or sibling with known AD-causing mutation)
    2.Are within -15 to + 10 years of the parental age of symptom onset
    3. CDR 0-1 inclusive
    4. Are able to undergo MRI, LP, PET, and complete all study related testing and evaluations.
    I soggetti devono soddisfare TUTTI i criteri di inclusione:
    [1] Mutazione accertata che causa la malattia di Alzheimer o mancata conoscenza del proprio stato genetico e probabilità del 50% di presentare una mutazione che causa la malattia di Alzheimer (ad es. genitore o fratello/sorella che presenta una mutazione che causa la malattia di Alzheimer)
    [2] Età compresa tra -15 e +10 anni rispetto all'età in cui sono insorti i sintomi del genitore
    [3] CDR compreso tra 0 e 1
    [4] Soggetti in grado di essere sottoposti a RM, puntura lombare, PET e di completare tutti gli esami e le valutazioni correlati allo studio.
    E.4Principal exclusion criteria
    Subjects will be excluded if they have a major or unstable illness or are unable to complete all study related testing. Exclusions include implanted metal that cannot be removed for MR scanning, required anticoagulation and pregnancy. Baseline MRI scan indicative of any other significant abnormality, including more than 4 definite micro hemorrhages. Clinically relevant abnormalities in chemistry, hematology or coagulation studies.
    I soggetti saranno esclusi se soffrono di una malattia importante o instabile oppure se non sono in grado di essere sottoposti a tutti gli esami correlati allo studio. Le esclusioni comprendono presenza di impianti in metallo che non possono essere rimossi prima della RM, necessità di terapia anticoagulante e gravidanza. Risonanza magnetica basale indicativa di qualunque altra significativa anomalia, tra cui più di 4 microemorragie definite. Alterazioni clinicamente rilevanti negli studi di chimica, ematologia e coagulazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is specific for each drug based on mechanism of action. Each primary endpoint for study drugs is listed in the drug-specific appendix. Endpoints include:

    1) Cerebral amyloid imaging using [11C]PiB-PET. Change in the amount of fibrillar amyloid deposition as measured by [11C]PiB-PET scans is the primary outcome for gantenerumab. Most mutation carriers who are in the range of -15 to + 10 years of dementia onset have increased [11C]PiB-PET signal in some brain regions (see Figure 1 above and Bateman et al., 2012). The composite PiB standardized uptake value ratio (C-SUVR, the composite SUVR of precuneous, caudate, gyrus rectus, occipital cortex, parietal cortex, prefrontal cortex and temporal cortex) is used as the primary outcome.

    2) Free and Total Abeta isoforms in CSF. The concentrations of CSF Aβ species will be the primary outcome for solanezumab, specifically different treatment effects on free (unbound) CSF Aβ42 (increase or no change) and free CSF Aβ40 (decrease) with comparable treatment-associated increases in CSF total (bound + unbound) Aβ42 and total Aβ40 after 104 weeks. An increase, or “normalization” of free CSF Aβ42 levels, is postulated to represent increased egress of Aβ42 from brain to CSF (Siemers et al., 2010).
    L'endpoint primario di efficacia è specifico per ogni farmaco basato sul meccanismo di azione. Ogni endpoint primario per i farmaci in studio è presente nell’appendice farmaco-specifica. Endpoints includono:
    1) Imaging dell’amiloide cerebrale usando [11C] PiB-PET. L’outcome primario per gantenerumab è la variazione nella quantità di deposito di amiloide fibrillare misurato da scansioni-PET [11C] PiB. La maggior parte dei portatori di mutazioni che sono nella gamma -15 fino a 10 anni per l’insorgenza della demenza mostrano un segnale PiB-PET [11C] aumentato in alcune regioni del cervello. Il rapporto del valore di assorbimento standardizzato composito con PiB (C-SUVR, media di precuneo, caudato, giro retto, corteccia occipitale, corteccia parietale, corteccia prefrontale e corteccia temporale) viene utilizzato usato come endpoint primario.
    2) Isoforme libere e totali di beta-amiloide (Aβ) nel liquido cerebrospinale. Le concentrazioni delle specie Aβ nel CSF costituiranno l'esito primario per solanezumab, specificamente diversi effetti del trattamento su CSF Aβ42 libero (non legato) (aumento o nessun cambiamento) e CSF Aβ40 libero (diminuzione) con analoghi aumenti associati al trattamento nel CSF di Aβ42 totale (legato + non legato ) e Aβ40 totale dopo 104 settimane. Un aumento, o una "normalizzazione" dei livelli di CSF Aβ42 libero si suppone rappresenti una maggiore uscita di Aβ42 dal cervello nel CSF (Siemers et al., 2010).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation at week 0, 52 & 104
    Settimane 0, 52 & 104
    E.5.2Secondary end point(s)
    Secondary study endpoints will include:
    1) Change in amyloid deposition as measured by [11C]PiB-PET C-SUVR (used as a secondary outcome measure when not the primary outcome measure).
    2) Change in CSF amyloid-beta peptide concentrations (used as a secondary outcome measure when not the primary outcome measure).
    3) Change of CSF biomarkers tau and ptau181 values compared between subjects on active drug (gantenerumab or solanezumab) and mutation carriers in the pooled placebo group.
    4) Rate of brain atrophy in treatment groups vs. pooled placebo group as measured by cortical thickness of regions of interest (volumetric MRI).
    5) Change in FDG-PET metabolism in specific regions of interest (e.g., precuneus) in treated group as compared to pooled placebo group measured.
    1. Variazione del deposito di amiloide misurata mediante il SUVR composito con [11C]-PiB-PET (C-SUVR, utilizzato come parametro degli esiti secondari quando non è un parametro degli esiti primari).
    2. Variazione delle concentrazioni di peptide beta-amiloide nel liquido cerebrospinale (utilizzata come parametro degli esiti secondari quando non è un parametro degli esiti primari).
    3. Variazione dei valori dei biomarcatori tau e ptau181 nel liquido cerebrospinale confrontata tra i soggetti trattati con farmaco attivo (gantenerumab o solanezumab) e i portatori della mutazione nel gruppo placebo raggruppato.
    4. Tasso di atrofia cerebrale nei gruppi di trattamento attivo rispetto al gruppo placebo raggruppato, misurato mediante lo spessore corticale delle regioni di interesse (RM volumetrica).
    5) Variazione del metabolismo con FDG-PET in regioni di interesse specifiche (ad es. precuneo) nel gruppo trattato con farmaco attivo rispetto al gruppo placebo raggruppato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same criteria as above for the primary endpoint.
    Stessi criteri come per l'endpoint primario.
    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 No
    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) 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 EEA15
    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
    France
    Italy
    Spain
    Sweden
    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
    The end of the study is week 112 (protocol p76/114); for gantenerumab = week 112 (page 95/114);
    ref xxxii: for Solanezumab =week 104 + End of Stufy visit needed if there are safety concerns that require follow-up (= week 112)
    La conclusione dello studio è la settimana 112 (protocollo p76/114); per
    gantenerumab settimana = 112 (pagina 95/114);
    per solanezumab = settimana 104 + visita di conclusione dello studio, necessaria se
    ci sono problemi di sicurezza che necessitano di follow-up (= settimana 112)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 210
    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)
    Standard of care
    Standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Washington University in St. Louis School of Medicine
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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