Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-000307-17

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

DIAN-TU-001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01760005

A.5.4

Other Identifiers

Name:

The Alzheimer's Association Grant

Number:

DIAN TTU-12-243040

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Washington University in St. Louis
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Hoffman LaRoche; Eli Lilly; The Alzheimer's Association; AVID Radio Pharmaceuticals
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Washington University in St. Louis
B.5.2	Functional name of contact point	Susan Mills, Sr. Project Manager
B.5.3	Address:
B.5.3.1	Street Address	4488 Forest Park Ave., Suite 301,
B.5.3.2	Town/ city	St Louis
B.5.3.3	Post code	MO 63108
B.5.3.4	Country	United States
B.5.4	Telephone number	+1-949-293-5290
B.5.5	Fax number	1-314-747-7060
B.5.6	E-mail	millss@neuro.wustl.edu

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Solanezumab
D.3.2	Product code	LY2062430
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Solanezumab
D.3.9.1	CAS number	955085-14-0
D.3.9.2	Current sponsor code	LY2062430
D.3.9.3	Other descriptive name	SOLANEZUMAB
D.3.9.4	EV Substance Code	SUB37126
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Gantenerumab
D.3.2	Product code	RO4909832
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gantenerumab
D.3.9.1	CAS number	645-35-2
D.3.9.2	Current sponsor code	ro4909832
D.3.9.3	Other descriptive name	HISTIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB14110MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Amyvid
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V., Grootslag 1‑5, NL‑3991 RA - Houten, The Netherlands
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Florbetapir (18F)
D.3.2	Product code	Florbetapir (18F)
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Florbetapir (18F)
D.3.9.3	Other descriptive name	FLORBETAPIR F18
D.3.9.4	EV Substance Code	SUB31310
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	720 to 2090
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Autosomal Dominant Alzheimer's disease

Malattia di Alzheimer autosomica dominante

E.1.1.1

Medical condition in easily understood language

Alzheimer's disease

Malattia di Alzheimer

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint of evaluation at week 0, 52 & 104

Settimane 0, 52 & 104

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability

Tollerabilità

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If 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.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

189

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In 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

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Washington University in St. Louis School of Medicine
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-30

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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