Clinical Trials Register

Summary
EudraCT Number:	2016-003669-24
Sponsor's Protocol Code Number:	NET-2011-02346784
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-10-01
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

2016-003669-24

A.3

Full title of the trial

Amyloid PET imaging study for the diagnosis of Alzheimer's disease in the preclinical/predementia phase

Studio della PET con tracciante per l’amiloide per la diagnosi della malattia di Alzheimer in fase preclinica/predemenza.

A.3.1

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

Amyloid PET imaging study for the diagnosis of Alzheimer's disease in the preclinical/predementia phase

Studio della PET con tracciante per l’amiloide per la diagnosi della malattia di Alzheimer in fase preclinica/predemenza

A.3.2

Name or abbreviated title of the trial where available

Non Disponibile

A.4.1

Sponsor's protocol code number

NET-2011-02346784

A.5.4

Other Identifiers

Name:

Number:

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	OSPEDALE SAN RAFFAELE
B.1.3.4	Country	Italy
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	Grant Ministeriale RF (NET-2011-02346784)
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Reparto Medicina Nucleare Ospedale San Raffaele
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ospedale San Raffaele
B.5.2	Functional name of contact point	Reparto di Medicina Nucleare
B.5.3	Address:
B.5.3.1	Street Address	Via Olgettina 60
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 26432224
B.5.5	Fax number	02 26435202
B.5.6	E-mail	perani.daniela@hsr.it

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	NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
D.2.1.1.2	Name of the Marketing Authorisation holder	PIRAMAL IMAGING GMBH
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Neuraceq
D.3.2	Product code	[18F]Florbetaben
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.3.9.2	Current sponsor code	[18F]Florbetaben
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

memory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phases

disturbo di memoria, declino cognitivo lieve, malattia di Alzheimer in fase prodromica/predemenza e di demenza

E.1.1.1

Medical condition in easily understood language

cognitive disorders

disturbi cognitivi

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	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10050727
E.1.2	Term	RI scan
E.1.2	System Organ Class	100000004848

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 study the diagnostic accuracy of semiquantitative single-subject analysis of [18F]Florbetaben PET imaging as early marker of Alzheimer’s disease in subjects with memory complaint

valutare l’accuratezza diagnostica della metodica PET con tracciante per l’amiloide ([18F]Florbetaben) analizzata a livello del singolo soggetto e con metodi semi-quantitativi come marcatore precoce di malattia di Alzheimer in soggetti affetti da disturbo cognitivo di memoria

E.2.2

Secondary objectives of the trial

to correlate the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI e [18F]FDG-PET data (acquired before the enrolment in the present study)

correlare il carico amiloideo con le misure neuropsicologiche, gli indici clinici, i valori di Aß42, Tau totale e fosfo-Tau e con i dati di RM e [18F]FDG-PET precedentemente acquisiti per scopi diagnostici

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

diagnosis of memory complaint, mild cognitive impairment or Alzheimer disease; age > 18 years old

diagnosi di disturbo soggettivo di memoria, declino cognitivo lieve o malattia di Alzheimer in fase lieve; età > 18 anni

E.4

Principal exclusion criteria

presence of other neurological and clinical condition responsible of cognitive disorders; liver and kidney failure; pregnancy and breastfeeding; fertile women do not using contraceptive drugs; hypersensitivity to active principle and excipients (ascorbic acid; anidre ethanol; macrogol 400; ascorbic sodium; water for injections)

evidenza di patologie cerebrali focali, fisiche, psichiatriche o metaboliche che possano altrimenti spiegare i disturbi cognitivi; pazienti con insufficienza epatica o renale; donne in gravidanza o in allattamento; donne fertili che non fanno uso di contraccettivi, ipersensibilità al principio attivo o a uno qualsiasi dei seguenti eccipienti: acido ascorbico, etanolo anidro, macrogol 400, sodio ascorbato, acqua per preparazioni iniettabili

E.5 End points

E.5.1

Primary end point(s)

to define the role of amyloid burden quantification in the early diagnosis of Alzheimer disease

definire il valore del carico di proteina amiloide studiato con PET con tracciante [18F]Florbetaben in soggetti con malattia di Alzheimer in fase prodromica/predemenza

E.5.1.1

Timepoint(s) of evaluation of this end point

at the end of the study

alla fine dello studio

E.5.2

Secondary end point(s)

to evaluate the relationship between the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI and [18F]FDG-PET data (acquired before the enrollment in the present study)

E.5.2.1

Timepoint(s) of evaluation of this end point

at the end of the study

alla fine dello studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

LVLS

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

180

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)

none

non è previsto alcun programma per il trattamento al termine della sperimentazione clinica

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

2017-01-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-08-31

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