Clinical Trials Register

Summary
EudraCT Number:	2011-001598-25
Sponsor's Protocol Code Number:	IG1002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2011-001598-25

A.3

Full title of the trial

A multicenter, randomized, controlled study to evaluate the efficacy and safety of short-term plasma exchange followed by long-term plasmaphereses with infusion of human albumin combined with intravenous immunoglobulin in patients with mild-moderate Alzheimer's disease.

Estudio multicéntrico, aleatorizado y controlado para evaluar la eficacia y seguridad del recambio plasmático a corto plazo seguido de plasmaféresis a largo plazo con infusiones de albúmina humana combinada con inmunoglobulina intravenosa en pacientes con enfermedad de Alzheimer leve-moderada.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Combined treatement with human albumin and intravenous immunoglobulin in Alzheimer disease

Tratamiento combinado con albúmina humana e inmunoglobulina intravenosa en enfermedad de Alzheimer.

A.4.1

Sponsor's protocol code number

IG1002

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	INSTITUTO GRIFOLS, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Instituto Grifols, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	INSTITUTO GRIFOLS, S.A.
B.5.2	Functional name of contact point	LAURA NÚÑEZ
B.5.3	Address:
B.5.3.1	Street Address	POLIGONO LEVANTE, C/CAN GUASH 2
B.5.3.2	Town/ city	PARETS DEL VALLES
B.5.3.3	Post code	08150
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34935710992
B.5.5	Fax number	+34935710381
B.5.6	E-mail	laura.nunez@grifols.com

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	Yes
D.2.1.1.1	Trade name	ALBUTEIN 5%
D.2.1.1.2	Name of the Marketing Authorisation holder	Instituto Grifols, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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.3.9.3	Other descriptive name	HUMAN SERUM ALBUMIN
D.3.9.4	EV Substance Code	SUB20344
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	Yes
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.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	Yes
D.2.1.1.1	Trade name	ALBUTEIN 20%
D.2.1.1.2	Name of the Marketing Authorisation holder	Instituto Grifols, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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.3.9.3	Other descriptive name	HUMAN SERUM ALBUMIN
D.3.9.4	EV Substance Code	SUB20344
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
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	Yes
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	Yes
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.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	Flebogamma DIF 50 mg/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	Instituto Grifols, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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.3.9.1	CAS number	308067-58-5
D.3.9.3	Other descriptive name	IMMUNOGLOBULIN G
D.3.9.4	EV Substance Code	SUB20618
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	Yes
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.IMP: 4
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	Flebogamma DIF 100mg/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	Instituto Grifols, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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.3.9.1	CAS number	308067-58-5
D.3.9.3	Other descriptive name	IMMUNOGLOBULIN G
D.3.9.4	EV Substance Code	SUB20618
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Mild to Moderate Alzheimer's Disease patients.

Pacientes con enfermdedad de Alzheimer leve-moderada.

E.1.1.1

Medical condition in easily understood language

Mild to Moderate Alzheimer's Disease patients.

Pacientes con enfermdedad de Alzheimer leve-moderada.

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10012271
E.1.2	Term	Dementia Alzheimer's type
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales

Evaluar los cambios cognitivos, funcionales, conductuales y los dominios globales basados en las diferentes escalas y baterías psicométricas aplicables.

E.2.2

Secondary objectives of the trial

To determine the changes in the concentration of beta-amyloid peptide in plasma and cerebrospinal fluid (CSF) in the treatment group of patients with Alzheimer’s disease (AD).
To evaluate the structural changes in volume of the hippocampus, posterior cingular area, and other associated areas based on neuroimaging studies with Magnetic Resonance Imaging (MRI) (variations versus baseline).
To determine functional brain functional changes through FDG-PET (fluordeoxyglucose-PET).
To determine whether plasma exchange with human albumin combined with intravenous immunoglobulin (IVIG) is safe, taking into account the following factors:
-Type, severity and frequency of adverse reactions during and after the procedure and infusions.
-Changes in vital signs and clinically relevant changes, according to the laboratory test findings.

Determinar los cambios de concentración del péptido beta-amiloide en plasma y en líquido cefaloraquídeo (LCR) en el grupo tratamiento de los pacientes con enfermedad de Alzheimer (EA).
Evaluar los cambios estructurales del volumen del hipocampo, el area posterior del cíngulo, y otras areas asociadas en base a los estudios de neuroimagen con Resonancia Magnética (RM) (variaciones respecto a la basal).
Determinar los cambios funcionales del cerebro con FDG-PET (fluordeoxiglucosa-PET).
Determinar si el recambio plasmático con albúmina humana combinado con immunoglobulina intravenosa (IGIV) es seguro, teniendo en cuenta los siguientes factores:
-Tipo, severidad y frecuencia de las reacciones adversas durante y después del procedimiento y de las infusiones.
-Cambios en los signos vitales y cambios clínicos relevantes de acuerdo con los hallazgos en los tests de laboratorio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Males or females between 55-85 years of age at the time of signing of the informed consent document.
2.A diagnosis of AD (NINCDS-ADRDA criterion), and Mini-mental Status Examination (MMSE) score between ≥18 and ≤26.
3.Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
4.The patient and a close relative or legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).
5.The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.
6.A brain Computed Axial Tomography (CAT) or Magnetic Resonance Imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, must be available.
7.A stable care taker must be available, and must attend the patient study visits.

1.Hombres o mujeres entre 55-85 años en el momento de firmar el consentimiento informado.
2.Que se les haya diagnosticado una enfermedad de Alzheimer (según los criterios del NINCDS-ADRDA), y una puntuación en el Mini-mental Status Examination (MMSE) entre ≥18 y ≤26.
3.Estar en tratamiento estable con inhibidores de la acetilcolinesterasa (AChEIs) durante los últimos 3 meses.
4.El paciente y el familiar allegado o representante legal deben leer la hoja de información al paciente, estar de acuerdo con la participación en el ensayo, y después firmar el consentimiento informado (el propio paciente o el familiar allegado/representante legal).
5.El paciente debe ser capaz de seguir el protocolo del estudio, recibir el tratamiento en el periodo de tiempo establecido y continuar durante el periodo de seguimiento.
6.Disponer de una Tomografía Axial Computerizada (TAC) craneal o una Resonancia Magnética (RM) dentro de los 12 meses previos al reclutamiento, mostrando ausencia de lesión cerebrovascular.
7.Un cuidador estable debe estar disponible y debe atender a las visitas del estudio del paciente.

E.4

Principal exclusion criteria

1.Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
•Hypocalcemia (Ca++ < 8.7 mg/dL).
•Thrombocytopenia (<100,000/L).
•Fibrinogen <1.5 g/L.
•Prothrombin time (Quick) p<60% versus control.
•Beta-blocker treatment and bradycardia <60/min.
•Treatment with angiotensin-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions).
2.Hemoglobin < 10 g/dL
3.Difficult venous access precluding plasma exchange.
4.A history of frequent adverse reactions (serious or otherwise) to blood products.
5.Hypersensitivity to albumin or allergies to any of the components of Albutein®.
6.History of immunoglobulin A (IgA) deficiency.
7.Known allergies to Flebogamma® DIF components such as sorbitol.
8.History of thromboembolic complications of intravenous immunoglobulins.
9.Plasma creatinine > 2 mg/dL.
10.Uncontrolled high blood pressure.
11.Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
12.Heart diseases, including antecedents of coronary disease and heart failure.
13.Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
14.Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
15.Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
16.Fewer than six years of education.
17.Prior behavioral disorders requiring pharmacological treatment, including insomnia

1.Cualquier contraindicación para el recambio plasmático debido a trastornos de conducta o parámetros de coagulación anormales, como por ejemplo:
•Hipocalcemia (Ca++ < 8.7 mg/dL).
•Trombocitopenia (<100,000/L).
•Fibrinógeno <1.5 g/L.
•Tiempo de protrombina (Quick) p<60% versus el control.
•Tratamiento con betabloqueantes y bradicardia <60/min.
•Tratamiento con inhibidores de la enzima convertidora de angiotensina (IECA) (aumento del riesgo de reacciones alérgicas).
2.Hemoglobina < 10 g/dL
3.Difícil acceso venoso impidiendo el recambio plasmático.
4.Antecedentes de reacciones adversas frecuentes (ya sean graves o no) a productos hemoderivados.
5.Hipersensibilidad a la albúmina o alergias a cualquier componente de la Albutein®.
6.Antecedentes de deficiencia de immunoglobulina A (IgA).
7.Alergias conocidas a componentes de Flebogamma® DIF tales como el sorbitol.
8.Antecedentes de complicaciones tromboembólicas con immunoglobulinas intravenosas.
9.Creatinina plasmática > 2 mg/dL.
10.Hipertensión arterial descontrolada.
11.Cirrosis hepática o cualquier alteración hepática con alanina aminotransferasa (GPT) > 2,5 x LSN ó bilirrubina > 2 mg/dl.
12.Enfermedades cardíacas incluyendo antecedentes de enfermedades coronarias e insuficiencia cardíaca.
13.Haber participado en otros ensayos clínicos o haber recibido cualquier otro fármaco en investigación durante los 3 primeros meses previos al inicio del estudio.
14.Cualquier condición que dificulte el cumplimiento del protocolo (enfermedades con menos de un año de supervivencia, hábitos tóxicos, etc.).
15.Mujeres embarazadas o en periodo de lactancia o mujeres que no usen un método anticonceptivo adecuado como mínimo hasta 1 mes después del recambio plasmático.
16.Nivel de estudios inferior a 6 años de escolarización.
17.Alteraciones de conducta previas que requieran tratamiento farmacológico, incluyendo el insomnio.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in the cognitive scores as measured by ADAS-Cog

Cambios respecto a la basal en las puntuaciones cognitivas obtenidas con el ADAS-Cog.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 measurements: weeks -2 or -1, and 6, months 5, 8, 11 and 14 within the 3 treatment arms.

6 mediciones: semana -2 o -1, y 6, meses 5, 8, 11 y 14) en los 3 brazos de tratamiento.

E.5.2

Secondary end point(s)

Change from baseline in the cognitive, functional and neuropsychiatric scores and overall development as measured by MMSE, NPS battery, ADL-ADCS and NPI.
Variation in levels of Ab40 and Ab42 in CSF in the period between baseline lumbar puncture (before the start of the Intensive treatment period) and lumbar puncture immediately after the end of the last low-volume plasmapheresis (whenever this may be).
Variation in the levels of Ab40 and Ab42 in CSF.
Levels of Ab40 and Ab42, T-tau and P-tau in CSF.
Plasma levels of Ab40 and Ab42 before and after each plasma exchange for both treatment periods.
Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by MRI.
Variation in FDG-PET patterns.

Cambios respecto a la basal en las puntuaciones de las pruebas cognitivas, funcionales y neuropsiquiátricas y la evolución global, medido por el MMSE, batería NPS, ADL-ADCS y NPI.
Variación en los niveles de Ab40 y Ab42 en LCR en el periodo comprendido entre la punción lumbar basal (antes del inicio del tratamiento) y la punción lumbar inmediatamente posterior a la finalización del último recambio plasmático, cuando quiera que éste se produzca.
Variación en los niveles de Ab40 y Ab42 en el LCR.
Niveles de Ab40 y Ab42, T-tau y P-tau en LCR.
Niveles plasmáticos de Ab40 y Ab42 antes y después de cada recambio plasmático en ambos periodos de tratamiento.
Cambios estructurales en el volumen del hipocampo, la zona posterior del cíngulo y otras zonas asociadas por RM.
Variación en los patrones de FDG-PET.

E.5.2.1

Timepoint(s) of evaluation of this end point

MMSE, NPS battery, ADL-ADCS and NPI. (6 measurements: week -2 or -1, and 6, month 5, 8, 11 and 14).
Ab40 and Ab42 in CSF in the period between baseline lumbar puncture (before the start of the Intensive treatment period) and lumbar puncture immediately after the end of the last low-volume plasmapheresis.
Ab40 and Ab42 in CSF between the finalization and beginning of each of the two treatment periods.
Ab40 and Ab42, T-tau and P-tau in CSF throughout the study.
Plasma levels of Ab40 and Ab42 before and after each plasma exchange for both treatment periods.
MRI: Three measurements will be made (week -2 or -1, months 6 and 14).
FDG-PET (3 measurements: weeks -1 or -2, months 6 and 14).

MMSE, batería NPS, ADL-ADCS y NPI. (6 mediciones: semana -2 o -1, y 6, meses 5, 8, 11 y 14).
Ab40 y Ab42 en LCR en el periodo comprendido entre la punción lumbar basal (antes del inicio del tratamiento) y la punción lumbar inmediatamente posterior a la finalización del último recambio plasmático.
Ab40 y Ab42 en el LCR entre la finalización y el inicio de 2 periodos de tratamiento.
Ab40 y Ab42, T-tau y P-tau en LCR durante todo el estudio.
Niveles plasmáticos de Ab40 y Ab42 antes y después de cada recambio plasmático en ambos periodos de tratamiento.
RM: Se harán 3 mediciones (semana -2 o -1, meses 6 y 14).
FDG-PET (3 mediciones: semana -1 o -2, meses 6 y 14).

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Procedure simulation

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

United States

E.8.7

Trial has a data monitoring committee

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

Last visit last patient.

Última visita del último paciente.

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

Number of subjects for this age range:

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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Alzheimer's disease subjects.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

250

F.4.2.2

In the whole clinical trial

350

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 treatment schedule after de subject has finnished the study participation is not different from the expected treatment for this disease.

Los planes de tratamiento o cuidado después que el sujeto haya terminado la participación en el estudio no es diferente del tratamiento esperado para esta enfermedad.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-10-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-03-06

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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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