Clinical Trials Register

Summary
EudraCT Number:	2018-003473-94
Sponsor's Protocol Code Number:	TauinAD_protocole_v2_20180718
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:	2019-03-28
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

2018-003473-94

A.3

Full title of the trial

Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms.

Imagerie des protéines tau et amyloide dans le vieillissement normal, la maladie d'Alzheimer débutante, et les syndromes apparentés.

A.3.1

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

Tau and Amyloid PET imaging in normal aging, early Alzheimer's disease and related syndroms.

Imagerie des protéines tau et amyloide dans le vieillissement normal, la maladie d'Alzheimer débutante, et les syndromes apparentés.

A.4.1

Sponsor's protocol code number

TauinAD_protocole_v2_20180718

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	Cliniques Universitaires Saint-Luc - UCLouvain
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	FNRS
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Cliniques Universitaires Saint-Luc - UCLouvain
B.5.2	Functional name of contact point	Pr Renaud Lhommel (Nuclear Med.)
B.5.3	Address:
B.5.3.1	Street Address	Avenue Hippocrate 10
B.5.3.2	Town/ city	1200 Brussels
B.5.3.4	Country	Belgium
B.5.4	Telephone number	3227642561
B.5.5	Fax number	3227645408
B.5.6	E-mail	renaud.lhommel@uclouvain.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	No
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	F18-MK6240
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 bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	[18F]MK6240
D.3.9.1	CAS number	1841078-87-2
D.3.9.3	Other descriptive name	6-[18F]fluoro-3-(1H-pyrrolo[2,3-c]pyridin-1- yl)isoquinolin-5-amine
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	185 to 7887
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 (AD)

E.1.1.1

Medical condition in easily understood language

Alzheimer is defined pathologically by the presence of tau tangles and amyloid senile plaques in the neocortex. To quantify pTAU in vivo, p-tau PET tracers have now been developed, like F18-MK6240.

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

Overall goal: evaluate tau PET imaging using the new MK6240 tracer
Tau PET imaging is likely to be more predictive of memory decline in the short run than amyloid. It could also help monitor the effect of potential new drugs in clinical trials. Anti-amyloid drugs have indeed failed to prove effective in patients with AD dementia. Tau can also be measured in the cerebrospinal fluid (CSF). However, this requires performing a lumbar puncture, a procedure that is more invasive than a PET scan and that does not allow to visualize where tau accumulates in the brain. As neurological symptoms depend on the topography of brain lesions, it is likely that the specific cognitive domains (language, memory...) in which an individual will have impairment will depend on the topography of tau deposition.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

ADNI (AD neuroimaging initiative) criteria will be applied for MCI and AD diagnoses. Seventy-five controls (age: 20-90) without significant memory complaints will be recruited by advertising and among children and siblings of AD patients. 50% will have family history of late-onset AD, starting after age 60. MMSE will be at least 26/30. 30 MCI and 20 AD patients will be recruited at the Memory Clinic of St-Luc Hospital. Memory complaints will be confirmed by an informant or the physician. For MCI, MMSE ≥ 24 will be required and dementia will be excluded using DSM IV criteria. Neurological exam will be normal and the same exclusion criteria will be
used for both controls and patients. 25 subjects with suspected non-AD tauopathies will also be recruited at St-Luc Hospital, using clinical guidelines for fronto-temporal dementia, supranuclear palsy, and corticobasal degeneration.

E.4

Principal exclusion criteria

MRI non-eligible, major depression or other psychiatric diseases, past or present neurological conditions (stroke, head trauma, Parkinson, MS), alcohol and drug abuse. Subjects with known or
suspected (familial history before age 60) autosomal dominant mutation for AD will also be excluded.

E.5 End points

E.5.1

Primary end point(s)

Correlation between p_TAU PET imaging quantification and local deposition with the patient's clinical cognitive and global neurological/neuro-psychological evolution.

E.5.1.1

Timepoint(s) of evaluation of this end point

A four-year cognitive follow-up is planned in the study as well as repeated imaging sessions after two and four years. The study is scheduled to end on December 31st, 2025

E.5.2

Secondary end point(s)

(1) Disentangle the effect of age and genetics on amyloid (Aβ) and tau deposits in normal aging
(2) Disentangle the effect of Aβ and tau on brain functions in MCI and early AD
(3) Evaluate how different PET ligands distinguish AD from non-AD tauopathies
(4) Evaluate how Aβ and tau PET imaging are able to predict progression to AD dementia (5) Compare Aβ and tau PET imaging to Aβ and tau measured in the CSF

E.5.2.1

Timepoint(s) of evaluation of this end point

A four-year cognitive follow-up is planned in the study as well as repeated imaging sessions after two and four years. The study is scheduled to end on December 31st, 2025

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

last visit of the last subject undergoing the trial

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)

F.1.3.1

Number of subjects for this age range:

105

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

150

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

2019-05-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-18

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

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