Clinical Trials Register

Summary
EudraCT Number:	2014-000562-21
Sponsor's Protocol Code Number:	PI-001
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-01-05
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

Netherlands - Competent Authority

A.2

EudraCT number

2014-000562-21

A.3

Full title of the trial

Amyloid-PET as a diagnostic marker in daily practice.

Amyloid-PET als een diagnostische marker in de dagelijkse praktijk.

A.3.1

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

A diagnostic marker to visualize Alzheimer pathology using a PET scan.

Een diagnostische marker voor het in beeld brengen van Alzheimer pathologie met behulp van een PET-scan.

A.4.1

Sponsor's protocol code number

PI-001

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	VU University Medical Center
B.1.3.4	Country	Netherlands
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	Piramal
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	VU University Medical Center
B.5.2	Functional name of contact point	Alzheimer Center
B.5.3	Address:
B.5.3.1	Street Address	De Boelelaan 1118
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1081 HZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310204440816
B.5.5	Fax number	00310204448529
B.5.6	E-mail	alzheimercentrum@vumc.nl

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
D.2.1.1.2	Name of the Marketing Authorisation holder	Piramal Imaging
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	Florbetaben
D.3.2	Product code	BAY949172
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 bolus use (Noncurrent)
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

Unselected patient population subjects visiting the memory clinic of the VUmc Alzheimer center.

Ongeslecteerde patient populatie welke het VUmc Alzheimercentrum bezoeken.

E.1.1.1

Medical condition in easily understood language

Patients visiting the VUmc Alzheimer Center.

Patienten die het VUmc Alzheimercentrum bezoeken.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

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 investigate in an unselected memory clinic sample, the clinical value of 18F]FBB PET in terms of
1. change in diagnosis;
2. change in level of confidence of diagnosis;
3. impact on patient healthcare management.

De klinische waarde van [18F]Florbetaben PET onderzoeken in termen van:
1. verandering van de diagnose;
2. verandering van de mate van zekerheid van de diagnose;
3. invloed op de medische behandeling.

E.2.2

Secondary objectives of the trial

not applicable.

niet van toepassing.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients of the VUmc Alzheimer Center with a written informed consent.

Patiënten van het VUmc Alzheimercentrum met een ondertekend toestemmingsformulier.

E.4

Principal exclusion criteria

Patients who
- are considered medically unstable (assessed by physician);
- require additional laboratory tests or workup between enrollment and completion of the [18F]FBB PET scan;
- are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breast feeding at screening. Females 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 [18F]FBB;
- are not able to give informed consent (personally or via authorized person) for whatever reason.

Patiënten die
- worden beschouwd als medisch instabiel (door behandelend arts);
- Extra laboratoriumtests of diagnostisch onderzoek vereisen tussen de inschrijving en voltooiing van de [18F]FBB scan;
- vrouwelijk zijn in de vruchtbare leeftijd en niet chirurgisch steriel, niet afzien van seksuele activiteit of geen betrouwbare methoden van anticonceptie gebruiken. Vruchtbare vrouwen mogen niet zwanger zijn (negatieve serum β-hCG ten tijde van de screening en negatieve urine β-hCG op de dag van de PET scan) of het geven van borstvoeding bij de screening. Vrouwen moeten gedurende 24 uur na toediening van [18F]FBB vermijden zwanger te worden en moeten akkoord gaan met zich te onthouden van seksuele activiteit of een betrouwbare anticonceptie methoden toepassen, zoals een voorgeschreven pil of spiraaltje;
- om wat voor reden (zelf of via een volgemachtigde) niet in staat zijn om een toestemmingsformulier te tekenen.

E.5 End points

E.5.1

Primary end point(s)

The main outcome measure is the clinical value of [18F]FBB PET, which will be operationalized as follows. (i), the change in diagnosis, (ii) change in the level of confidence in the diagnosis, (iii) the impact on future patient management as measured using additional ancillary investigations, prescription of medication and use of health care.
In addition, patients who do not (yet) have dementia (i.e. subjective complaints, MCI), clinical progression to MCI or dementia during annual follow-up (based on follow-up visits to neurologist and neuropsychologist) will serve as additional outcome measure. Furthermore, in a subset of demented patients we will obtain clinical follow-up to examine the relation with rate of progression.

De belangrijkste uitkomstmaat is de klinische waarde van [18F]FBB PET; deze wordt als volgt geoperationaliseerd. (i) verandering van diagnose, (ii) verandering van de mate van de zekerheid van diagnose, (iii) de impact op het medische beleid bij een patient (gemeten door te kijken naar gebruik van aanvullend onderzoek, voorschrijven van medicatie en gebruik van zorg). Daarnaast zal klinische progressie naar MCI of dementie tijdens jaarlijkse follow-up (gebaseerd op bezoek bij neuroloog en neuropsycholoog) bij patiënten die (nog) geen dementie hebben als additionele uitkomstmaat fungeren. Bovendien zal er van een deel van de patiënten met dementie klinisch follow-up plaatsvinden om te kijken naar de mate van progressie.

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation wil be executed after the last patient’s last visit.

Een evaluatie wordt uitgevoerd na het laatste bezoek van de laatste patient.

E.5.2

Secondary end point(s)

not applicable.

niet van toepassing.

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable.

niet van toepassing.

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.8.3

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.8.5

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

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

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.1.1.1

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:

350

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Elderly who have an authorized person to sign the informed consent (i.e. demented patients) will also be invited for this study.

Ouderen wie een volgemachtigde hebben toegewezen (bijvoorbeeld demente patiënten) zullen ook worden uitgenodigd voor deelname aan de studie.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

500

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.

Geen.

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

2015-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-18

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

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