Clinical Trials Register

Summary
EudraCT Number:	2012-003079-20
Sponsor's Protocol Code Number:	18F-AV-45-C02
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:	2012-12-28
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-003079-20

A.3

Full title of the trial

Evaluation of florbetapir (18F) PET in subjects participating in the IRCCSFBF protocol

Valutazione della scansione PET con florbetapir (18F) nei soggetti partecipanti al protocollo IRCCS-FBF

A.3.1

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

To test the effectiveness of florbetapir (18F) as a diagnostic tool in subjects particpiating in the IRCCS-FBF protocol

Per testare l'efficacia di florbetapir (18 F)come mezzo diagnostico nei soggetti partecipanti al protocollo IRCCS-FBF

A.4.1

Sponsor's protocol code number

18F-AV-45-C02

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	AVID RADIOPHARMACEUTICALS, INC.
B.1.3.4	Country	United States
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	Avid Radiopharmaceuticals, Inc.
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	Avid Radiopharmaceuticals, Inc.
B.5.2	Functional name of contact point	Mark J. Lowrey
B.5.3	Address:
B.5.3.1	Street Address	3711 Market Street, Suite 700
B.5.3.2	Town/ city	Philadelphia
B.5.3.3	Post code	PA 19104
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 215 298 0714
B.5.5	Fax number	+1 413 826 0416
B.5.6	E-mail	lowrey@avidrp.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	Amyvid
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly and Company and Avid Radiopharmaceuticals Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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 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.3.9.1	CAS number	1205550-99-7
D.3.9.2	Current sponsor code	18F-AV-45
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	370
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Alzheimer's disease and other neurodegenerative diseases, as for example Dementia with Lewy bodies, Parkinson Dementia, Vascular Dementia and Tau Protein associated Dementia.

Malattia di Alzheimer e altre malattie neurodegenerative, quali ad esempio la demenza con corpi di Lewy, la demenza di Parkinson, la demenza vascolare e le demenze associate alla proteina Tau.

E.1.1.1

Medical condition in easily understood language

Alzheimer's disease and other neurodegenerative diseases

Malattia di Alzheimer e altre malattie neurodegenerative

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	14.1
E.1.2	Level	HLT
E.1.2	Classification code	10001897
E.1.2	Term	Alzheimer's disease (incl subtypes)
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10001896
E.1.2	Term	Alzheimer's disease
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
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

a. To expand the database of florbetapir (18F) safety and positivity of Florbetapir (18F) in patients evaluated for a cognitive disorder in clinical setting and in elderly cognitively intact subjects

a. Espandere il database sulla sicurezza e sulla positività del Florbetapir (18F) in pazienti valutati per un disturbo cognitivo in setting clinici e in soggetti anziani sani cognitivamente integri

E.2.2

Secondary objectives of the trial

b. To provide standardized criteria for capturing and interpreting data obtained by PET imaging with Florbetapir (18F)

b. Fornire criteri standardizzati per l’acquisizione e l’interpretazione dei dati provenienti dall’esame PET con Florbetapir (18F)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects should have already met inclusion and exclusion criteria for the main protocol “Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: a) Patients with cognitive complaints who will be included in a diagnostic work-up to make a differential diagnosis; b) Age between 50 and 85 years; c) Patients who have an informant (spouse, adult child, or friend who knows the patient well) available for accompanying to visits. In addition: Subjects meet the following inclusion criteriona: 1. Subjects who sign an Independent Ethics Committee (IEC) approved informed consent form prior to any florbetapir (18F) PET procedures

I soggetti potranno essere arruolati in accordo ai criteri di inclusione/esclusione dello studio principale “Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, ovvero: a) Sono pazienti, che lamentano disturbi cognitivi, che saranno inseriti in un percorso di accertamento diagnostico di routine per poter compiere una diagnosi differenziale; b) Hanno un’età ≥ 50 e ≤ 85 anni; c) Hanno un informatore (moglie, marito, figlio adulto o amico che conosca bene il soggetto) disponibile ad accompagnarli alle visite. . In aggiunta, i soggetti potranno essere arruolati se in possesso del seguente requisito: 1. Hanno firmato un consenso informato approvato dal Comitato Etico prima di sottoporsi all’esame PET con Florbetapir (18F).;

E.4

Principal exclusion criteria

Subjects will be excluded from enrollment if they have already met exclusion criteria for the main protocol “Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: • Are MCI patients with a CDR (Clinical Dementia rating Scale) > 0,5 at baseline; AD and non-AD patients with a CDR (Clinical Dementia rating Scale) > 2 at baseline. In addition, subjects will be excluded from enrollment if they: : a. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan; b. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine β-hCG at the time of screening and negative urine β-hCG on the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F); c. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound); d. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ-secretase or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial; f. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; and g. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

I soggetti non potranno essere arruolati in accordo ai criteri di esclusione dello studio principale “Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, ovvero: . Sono pazienti MCI con un punteggio alla CDR (Clinical Dementia Rating Scale) > di 0.5 alla baseline; sono pazienti AD e non-AD con un punteggio alla CDR > 2 alla baseline. In aggiunta, i soggetti saranno esclusi dall’arruolamento se: a) I soggetti saranno esclusi dall’arruolamento se: a) Soffrono attualmente di una patologia psichiatrica clinicamente significativa a tal punto che il neurologo/geriatra ritiene il soggetto non in grado di completare la sessione di PET imaging. b) Sono donne potenzialmente fertili che non sono chirurgicamente sterili e che non garantiscono di non astenersi dall’attività sessuale per le 24 ore successive alla somministrazione di Florbetapir (18F). Le donne potenzialmente fertili non devono essere in stato di gravidanza (β- hCG urinaria negativa al momento dello screening e β-hCG urinaria negativa nel giorno della tomografia) o allattare al momento dello screening. Le donne in età fertile devono impegnarsi a non intraprendere una evitare la gravidanza nei 10 giorni precedenti alla scansione PET e durante le 24 ore successive alla stessa e gli uomini che partecipano allo studio dovranno impegnarsi a non far intraprendere evitare una gravidanza adella partner, garantendo l’astensione dai rapporti sessuali per le 24 ore successive alla somministrazione di Florbetapir (18F). c) Hanno una storia di grave allergia o ipersensibilità verso i farmaci (le allergie gravi ai farmaci devono essere attestate dallo sperimentatore principale (PI, Principal Investigator) o dal co-sperimentatore (Co-Principal Investigator) e qualsiasi domanda riguardante l’idoneità del soggetto può essere rivolta ad Avid Radiopharmaceuticals Inc. Se il soggetto ha una storia di gravi allergie ai farmaci, può essere pericoloso partecipare a uno studio con un composto nuovo). e) Hanno partecipato a uno studio sperimentale con una terapia anti-amiloide (ad es. immunoterapia, inibitore della secretasi), dunque non possono essere arruolati in questo studio a meno che si possa dimostrare che il soggetto ha ricevuto soltanto il placebo nel corso della sperimentazione. f) Stanno assumendo un farmaco sperimentale o hanno partecipato a una sperimentazione con farmaci sperimentali negli ultimi 30 giorni. g) Sono stati sottoposti a imaging o a procedure di trattamento utilizzando radiofarmaci nei 7 giorni precedenti la sessione di imaging di questo studio.

E.5 End points

E.5.1

Primary end point(s)

Qualitative assessment of image (ABETA+ or ABETA-)at PET imaging for amyloid with Florbetapir (18F). Quantitative regional assessment of amyloid deposits(SUVr) associated with the following brain regions: • Frontal cortex • Temporal cortex • Parietal cortex • Posterior cingular cortex • Anterior cingulate • Precuneus • Global average of all of the above

Valutazone qualitatita (ABETA+ oppure ABETA-) all'esame PET per l'amiloide con Florbetapir (18F). Valutazione quantitativa regionale dei depositi di amiloide (SUVr)associata alle seguenti regioni del cervello: .corteccia frontale .corteccia temporale .corteccia parietale .corteccia cingulare posteriore .cingulato anteriore .precuneo .media totale di tutti i precedenti

E.5.1.1

Timepoint(s) of evaluation of this end point

PET Imaging Day with Florbetapir (18F)

il giorno dell'esame PET con Florbetapir (18F)

E.5.2

Secondary end point(s)

n.a.

E.5.2.1

Timepoint(s) of evaluation of this end point

n.a.

n.a

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

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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.8.6 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

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

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

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

280

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)

A follow-up telephone call will be done 2 (+/-1) on working days to the subject (or to the caregiver if applicable)after the PET scan with Florbetapir (18F) to assess subject's clinical conditions and to collect information on possible new advers events

Una telefonata di follow-up al soggetto (o all'informatore se applicabile) sarà effettuata 2 (+/-1) giorni lavorativi dopo l'esame PET con Florbetapir (18F) per verificare le buone condizioni del soggetto e per raccogliere informazioni relative a eventuali nuovi eventi avversi

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

2013-01-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-24

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