Clinical Trials Register

Summary
EudraCT Number:	2013-004671-12
Sponsor's Protocol Code Number:	s55892
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-05-20
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2013-004671-12

A.3

Full title of the trial

Predictive value of biomarkers in patients with amnestic mild cognitive impairment

A.3.1

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

Predictive value of biomarkers in patients with amnestic mild cognitive impairment

A.4.1

Sponsor's protocol code number

s55892

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	University of Leuven
B.1.3.4	Country	Belgium
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 Imaging Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Leuven
B.5.2	Functional name of contact point	Memory Clinic
B.5.3	Address:
B.5.3.1	Street Address	Herestraat 49
B.5.3.2	Town/ city	Leuven
B.5.3.3	Post code	3000
B.5.3.4	Country	Belgium
B.5.6	E-mail	rik.vandenberghe@uzleuven.be

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 Limited
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	Neuraceq
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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

Mild cognitive impairment

E.1.1.1

Medical condition in easily understood language

Mild cognitive impairment

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

We will test the predictive value of baseline flutemetamol capture for longitudinal change in amyloid load measured using PET in MCI cases.
Second, we will compare CSF Aβ42 and amyloid PET for classification of amyloid-positive and amyloid negative cases. Third, we will compare the predictive value of CSF AD biomarkers Aβ42, T-tau and P-tau181P with that of amyloid imaging for MCI cases that progress to Alzheimer's disease.

E.2.2

Secondary objectives of the trial

Our secondary objectives include the evaluation of whether a change in amyloid deposition (measured by CSF Aβ42 or SUVR) over a 1 year period predicts cognitive decline over a 2 year time period and whether both measures contribute independently to this decline.
Further, we will analyze the predictive value of classical AD biomarkers changes after one year on the progression of cognitive change after 2 years. We will also explore the correlation of baseline exploratory candidate biomarkers.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient is male or female and between ≥ 55 and ≤ 85 years of age on the day of signing the consent form.
2. If female, patient is not of reproductive potential (two years post-menopausal or surgically sterile).
4. Patient has a subjective memory concern as reported by subject, study partner, or clinician.
5. Patient has an abnormal memory function documented by scoring within the
education adjusted ranges on the CANTAB memory performance (≥ -1SD).
6. Patient has a Global Clinical Dementia Rating score of 0 or 0.5.
7. In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
8. Patient has at least six years of education, or work history sufficient, in the investigator’s opinion, to exclude mental retardation.
9. Patient is fluent in written and verbal Dutch.

E.4

Principal exclusion criteria

1. Patient has a history or current evidence of a neurological disorder, that in the opinion of the primary investigator may contribute to the subject's cognitive impairment, including, but not limited to:
● Large-vessel stroke,
● epilepsy,
● Parkinson’s disease,
● progressive supranuclear palsy,
● Huntington’s disease,
● amyotrophic lateral sclerosis,
● multiple sclerosis,
● CNS infection,
● significant head trauma with loss of consciousness,
● Normal pressure hydrocephalus

2. Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions on baseline MRI scan that may contribute to the cause of the memory impairment in the opinion of the investigator. Vascular white matter lesions or other signs of microangiopathy will not be considered an exclusion.
3. Patient has a history within 6 months prior to screening visit or current evidence of a psychotic disorder or a major untreated depressive disorder.
4. Patient has a history of malignancy ≤5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year, and who are deemed at low risk for recurrence by her/his treating physician.
5. Patient has a history or current evidence of any potentially known clinically significant condition , therapy, lab abnormality or other circumstance that in the opinion of the investigator might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
6. Patients currently use specific psychoactive medications (neuroleptics, chronic anxiolytics, tricyclic antidepressants, antiepileptics, anticholinergics etc.). Stable dose trazodone, mirtazapine or low dose benzodiazepines prescribed for mild insomnia is allowed.
7. Patients currently use antithrombotics with the exception of acetyl salicylic acid (exclusionary for lumbar puncture).
8. Cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen.
9. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV
criteria)
10. Patient is currently participating or has participated in a study with an investigational compound or neuropsychological measures within 30 days of signing informed consent.
11. Subject has any magnetizable metal prostheses, implants or foreign objects that could pose a hazard during MRI scans.

E.5 End points

E.5.1

Primary end point(s)

Since this study is not interventional, no end points are defined.

E.5.1.1

Timepoint(s) of evaluation of this end point

not applicable

E.5.2

Secondary end point(s)

not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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:

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

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

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.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

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

2014-06-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-18

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

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