Clinical Trials Register

Summary
EudraCT Number:	2018-002548-10
Sponsor's Protocol Code Number:	CAAAMY
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:	2021-05-24
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

2018-002548-10

A.3

Full title of the trial

PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation

Studio PET/MRI del carico di amiloide in pazienti con angiopatia amiloide cerebrale infiammatoria

A.3.1

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

PET/MRI study of amyloid burden in patients with Cerebral Amyloid Angiopathy-related inflammation

Studio PET/MRI del carico di amiloide in pazienti con angiopatia amiloide cerebrale infiammatoria

A.3.2

Name or abbreviated title of the trial where available

CAA AMY

A.4.1

Sponsor's protocol code number

CAAAMY

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	Unità Operativa di Medicina Nucleare, IRCCS 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	IRCCS Ospedale San Raffaele
B.5.2	Functional name of contact point	Unità operativa di Medicina Nuclear
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	0226437053
B.5.5	Fax number	0226432717
B.5.6	E-mail	incerti.elena@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 300MBQ/ML SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO (VETRO) – 1 FLACONCINO MONODOSE
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	[18FFlorbetaben]
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.3.9.1	CAS number	902143-01-5
D.3.9.2	Current sponsor code	[18F]Florbetaben
D.3.9.3	Other descriptive name	[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

cerebral amyloid angiopathy related inflammation (CAA-ri)

angiopatia cerebrale amiloide infiammatoria (CAA-ri)

E.1.1.1

Medical condition in easily understood language

cerebral amyloid angiopathy related inflammation (CAA-ri)

angiopatia cerebrale amiloide infiammatoria (CAA-ri)

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10068044
E.1.2	Term	Cerebral amyloid angiopathy
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10068044
E.1.2	Term	Cerebral amyloid angiopathy
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 characterize the pattern of amyloid burden in patients with cerebral amyloid angiopathy- related inflammation

definire il pattern di deposizione della proteina amiloide in pazienti con angiopatia cerebrale amiloide infiammatoria

E.2.2

Secondary objectives of the trial

to define presence and severity of cerebrovascular damage in patients with cerebral amyloid angiopathy- related inflammation; to correlate data obtained from the amyloid-PET exam with specific parameters of cerebrovascular damage

definire entità e grado del danno cerebrovascolare in pazienti con angiopatia cerebrale amiloide infiammatoria; correlare il dato PET-amiloide con parametri specifici di danno cerebrovascolare

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

male patients; diagnosis of CAA-RI; age>55 years.

pazienti di sesso maschile; diagnosi di CAA-RI; età > 55 anni.

E.4

Principal exclusion criteria

Evidence of focal cerebral, physical, psychiatric or metabolic disorders that may otherwise account for the cognitive disturbances; patients with hepatic or renal insufficiency; hypersensitivity to the active substance or to any of the following excipients: ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, water for injections; wearers of pacemakers, clips or metal prostheses; contraindications to PET and MRI.
This medicine contains up to 1.5 mmol sodium (ie 33 mg) per dose. This must be taken into consideration in patients on a low sodium diet.
This medicine contains 15% by volume of ethanol (alcohol), that is up to 1.2 g per dose equivalent to 30 mL of beer or 12.5 mL of wine. This can be dangerous for those suffering from alcoholism, and must also be taken into consideration in high-risk groups such as patients with liver disease or epilepsy.

Evidenza di patologie cerebrali focali, fisiche, psichiatriche o metaboliche che possano altrimenti spiegare i disturbi cognitivi; pazienti con insufficienza epatica o renale; ipersensibilità al principio attivo o a uno qualsiasi dei seguenti eccipienti: acido ascorbico, etanolo anidro, macrogol 400, sodio ascorbato, acqua per preparazioni iniettabili; portatori di pacemaker, clips o protesi metalliche; controindicazioni alla PET e MRI.
Questo medicinale contiene fino a 1,5 mmol di sodio (cioè 33 mg) per dose. Questo deve essere tenuto in considerazione in pazienti sottoposti a dieta a basso contenuto di sodio.
Questo medicinale contiene il 15% in volume di etanolo (alcol), cioè fino a 1,2 g per dose equivalenti a 30 mL di birra o a 12,5 mL di vino. Questo può essere pericoloso per coloro che soffrono di alcolismo, e deve anche essere preso in considerazione in gruppi ad alto rischio quali pazienti con malattia epatica o epilessia.

E.5 End points

E.5.1

Primary end point(s)

use of [18F]Florbetaben radiotracer as a biomaker to be used in the clinical field, in combination with PET, in CAA-RI

utilizzo del radiotracciante [18]Florbetaben come biomarcatore applicabile in campo clinico, con metodi PET, nella CAA-RI

E.5.1.1

Timepoint(s) of evaluation of this end point

end of study

fine studio

E.5.2

Secondary end point(s)

correlation with cerebrovascular damage for diagnostic purposes

correlazione con danno cerebro-vascolare per scopi diagnostici

E.5.2.1

Timepoint(s) of evaluation of this end point

end of study

fine 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

Yes

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

Yes

E.8.2.3.1

Comparator description

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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:

F.2 Gender

F.2.1

Female

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

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

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

F.4.2.2

In the whole clinical trial

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)

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

2019-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-10

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

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