Clinical trial • Phase III • Neurology

TRONTINEMAB for Alzheimer's disease | Mild cognitive impairment

Phase III trial of TRONTINEMAB for Alzheimer's disease | Mild cognitive impairment.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Alzheimer's disease | Mild cognitive impairment
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Radiopharmaceutical

Key dates

Initial CTIS Submission Date
15-07-2025
First CTIS Authorization Date
04-11-2025

Trial design

Randomised, trontinemab (iv infusion) and placebo trontinemab (placebo comparator). dose and schedule not specified in ctis record.-controlled Phase III trial in Denmark, France, Italy and others.

Randomised
Yes
Comparator
Trontinemab (IV infusion) and Placebo Trontinemab (placebo comparator). Dose and schedule not specified in CTIS record.
Target Sample Size
553
Trial Duration For Participant
504

Eligibility

Recruits 553 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and consent documents for participant, caregiver and study partner are listed in the CTIS documents (e.g. 'L1_ICF Caregiver', 'L1_ICF Main', 'L1_SIS and ICF Study Partner'). An 'Infant Authorization' document is present in the document list, but specific consent/assent procedures or age-specific consent handling details are not provided in the CTIS JSON..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and consent documents for participant, caregiver and study partner are listed in the CTIS documents (e.g. 'L1_ICF Caregiver', 'L1_ICF Main', 'L1_SIS and ICF Study Partner'). An 'Infant Authorization' document is present in the document list, but specific consent/assent procedures or age-specific consent handling details are not provided in the CTIS JSON.

Inclusion criteria

  • {"criterion_text":"- Fluency in the language of the tests used at the study site\n- Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing\n- Evidence of AD pathological process as confirmed by amyloid positron emission tomography (PET) scan or CSF\n- Screening Mini-Mental State Examination (MMSE) score ≥ 22 and Clinical Dementia Rating, Global Score (CDR-GS) of 0.5 or 1.0\n- A Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index (DMI) score of 85 or lower\n- Availability of an appropriate study partner"}

Exclusion criteria

  • {"criterion_text":"- Any evidence of a condition other than AD that may affect cognition\n- Inability to tolerate MRI procedures or contraindication to MRI\n- Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant’s safety in the study or interfere with the study assessments\n- History or presence of clinically significant cerebrovascular disease\n- Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline\n- History of hypersensitivity to biologic agents or any of the excipients in the formulation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)","definition_or_measurement_approach":"Change from baseline measured at Week 72 using the Clinical Dementia Rating, Sum of Boxes (CDR-SB)."}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline through Week 72 in ▪ Alzheimer’s Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)","definition_or_measurement_approach":"Change from baseline through Week 72 measured by ADAS-Cog-13 score."}
  • {"endpoint_text":"- Change from baseline through Week 72 in ▪ Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score","definition_or_measurement_approach":"Change from baseline through Week 72 measured by ADCS-ADL total and instrumental scores."}
  • {"endpoint_text":"- Change from baseline through Week 72 in ▪ integrated Alzheimer’s Disease Rating Scale (iADRS)","definition_or_measurement_approach":"Change from baseline through Week 72 measured by iADRS."}
  • {"endpoint_text":"- Change from baseline through Week 72 in ▪ MMSE","definition_or_measurement_approach":"Change from baseline through Week 72 measured by Mini-Mental State Examination (MMSE)."}
  • {"endpoint_text":"- Time to increase in CDR-GS","definition_or_measurement_approach":"Time-to-event analysis for increase in Clinical Dementia Rating Global Score (CDR-GS)."}
  • {"endpoint_text":"- Nature, frequency, severity of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"Collection and analysis of AEs and SAEs (nature, frequency, severity) throughout study."}
  • {"endpoint_text":"- Change from baseline in clinical laboratory assessments and vital signs, physical examinations (including neurological systems), electrocardiograms (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Change from baseline in labs, vitals, physical exams, ECGs and C-SSRS."}
  • {"endpoint_text":"- Nature, frequency, severity, and timing of amyloid-related imaging abnormalities edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin Deposition (ARIA-H) MRI findings","definition_or_measurement_approach":"MRI assessments of ARIA-E and ARIA-H: recording nature, frequency, severity and timing."}
  • {"endpoint_text":"- Nature, frequency, severity, and timing of infusion-related reactions (IRRs)","definition_or_measurement_approach":"Monitoring and characterization of infusion-related reactions (IRRs)."}
  • {"endpoint_text":"- Incidence and titer of anti-drug antibodies (ADAs) to trontinemab during the study relative to the prevalence of ADAs at baseline.","definition_or_measurement_approach":"ADA assays to determine incidence and titer during study compared with baseline prevalence."}
  • {"endpoint_text":"- Change from baseline through Week 72 in brain amyloid load, as measured by amyloid positron emission tomography (PET) scan","definition_or_measurement_approach":"Amyloid PET imaging comparing baseline to Week 72 amyloid load."}
  • {"endpoint_text":"- Change from baseline to Week 72 in brain tau load, as measured by tau amyloid PET scan in a subset of participants","definition_or_measurement_approach":"Tau PET imaging in a subset to assess change from baseline to Week 72."}
  • {"endpoint_text":"- Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease phosphorylated tau 181 (p-tau181), Neurogranin, amyloid-beta 42 (Aβ42) in a subset of participants","definition_or_measurement_approach":"CSF biomarker assays (p-tau181, Neurogranin, Aβ42) in subset from baseline to Week 72."}
  • {"endpoint_text":"- Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)","definition_or_measurement_approach":"Blood biomarker assays (p-tau217, GFAP) assessing change from baseline to Week 72."}

Recruitment

Registry Or Advocacy Recruitment
True, Fundacio Ace Institut Catala De Neurociencies Aplicades (patient organisation) is listed among trial sites and may be involved in recruitment
Digital Remote Recruitment
True, CTIS documents reference digital and remote recruitment methods including social media posts, online banners, QR codes and Link2Trials materials
Planned Sample Size
553
Recruitment Window Months
30
Consent Approach
Informed consent is via subject information sheets and informed consent forms (multiple 'L1' and 'L2' documents listed). There are dedicated ICFs for participants, caregivers and study partners (e.g. 'L1_ICF Caregiver', 'L1_SIS and ICF Study Partner', 'L1_ICF Main'). Protocol synopses and some ICFs are available in multiple languages (English, Spanish, French, Italian, Dutch, Polish, German as evidenced by document translations and file names). Specific age-based assent procedures are not detailed in the CTIS JSON.

Methods

  • Study web postings (BRC sites) — documents: 'K2_ Recruitment material Study Web Posting BRC sites_EN_REDACTED' and NL version
  • Posters and flyers — multiple K2 recruitment materials (Poster, Flyer) listed for several countries
  • Social media support/posts — documents titled 'Social media support' and 'Social Media posts' for country-specific sites
  • Online banners and QR codes linking to recruitment pages — e.g. 'Online banner V1' and 'Roche_Alzheimer_RollUp QR_Code' documents
  • Link2Trials platform support — document 'K2_Recruitment material Link2Trials social media BRC sites_REDACTED'
  • Inclusive research guides and study web materials (country/language specific) referenced in K2 documents

Geography

Total Number Of Sites
90
Total Number Of Participants
252

Denmark

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
15
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Rigshospitalet
Department Name
Hukommelsesklinikken
Contact Person Name
Kristian Frederiksen
Site Name
Region Midtjylland
Department Name
Neurologisk forskning
Contact Person Name
Hanne Gottrup
Contact Person Email
Hagott@rm.dk
Site Name
Aalborg University Hospital
Department Name
Neurologisk Afdeling, Demensenheden
Contact Person Name
Karsten Vestergård
Contact Person Email
k.vestergaard@rn.dk

France

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
40
Number Of Sites
17
Number Of Participants
35

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hôpital Roger Salengro
Contact Person Name
Marie-Anne Mackowiak
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Hôpital Charles Nicolle
Contact Person Name
David Wallon
Contact Person Email
David.Wallon@chu-rouen.fr
Site Name
Hospices Civils De Lyon
Department Name
Hôpital des Charpennes
Contact Person Name
Sophie Dautricourt
Contact Person Email
sophie.dautricourt@chu-lyon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hôpital de la Timone
Contact Person Name
Mathieu Ceccaldi
Contact Person Email
mathieu.ceccaldi@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hôpital Pellegrin
Contact Person Name
Vincent Planche
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hôpital Dupuytren
Contact Person Name
Achille Tchalla
Contact Person Email
achille.tchalla@chu-limoges
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
CHU Amiens
Contact Person Name
Olivier Godefroy
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital La pitié Salpêtrière
Contact Person Name
Nicolas Villain
Contact Person Email
nicolas.villain@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hôpital neurologique Pierre Wertheimer
Contact Person Name
Hélène Mollion
Contact Person Email
helene.mollion@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Lariboisière Fernand-Widal
Contact Person Name
Claire Paquet
Contact Person Email
Claire.paquet@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hôpital Pontchaillou
Contact Person Name
Cezara-Roxona Hanta
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hôpital Bretonneau
Contact Person Name
Victoire Leroy
Contact Person Email
Victoire.leroy@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hôpital la Grave
Contact Person Name
Pierre-Jean Ousset
Contact Person Email
ousset.pj@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hôpital Gui de Chauliac
Contact Person Name
Audrey Gabelle
Contact Person Email
a-gabelle@chu-montpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hôpital de la Robertsau
Contact Person Name
Alix Ravier
Contact Person Email
alix.ravier@chru-strasbourg.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital Broca
Contact Person Name
Marie-Laure Seux
Contact Person Email
marie-laure.seux@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hôpital Laennec
Contact Person Name
Claire Boutoleau Bretonnière

Italy

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
45
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Departement of Biomedical, Metabolic and Neural Sciences
Contact Person Name
Giovanna Zamboni
Contact Person Email
giovanna.zamboni@unimore.it
Site Name
Fondazione Santa Lucia
Department Name
Neurologia e Riabilitazione Neurologica
Contact Person Name
Giacomo Koch
Contact Person Email
g.koch@hsantalucia.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.C. Neurologia
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Neurology
Contact Person Name
Fulvio Da Re
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
UOC Malattie Neurodegenerative
Contact Person Name
Giancarlo Logroscino
Contact Person Email
giancarlo.logroscino@uniba.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Neurologia
Contact Person Name
Camillo Marra
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. Neurologia
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dept. of Human Neurosciences - DAI Neuroscienze/Salute Mentale
Contact Person Name
Giuseppe Bruno
Contact Person Email
giuseppe.bruno@uniroma1.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Neurology
Contact Person Name
Matteo Pardini
Contact Person Email
matteo.pardini@unige.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Department of Neuroscience, Reproductivity Science and Odontostomatology
Contact Person Name
Vincenzo Brescia Morra
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
Neurologia
Contact Person Name
Emanuele Cassetta
Contact Person Email
emanuele.cassetta@afar.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Section of Neurology Dept. of Medicine and Surgery
Contact Person Name
Lucilla Parnetti
Contact Person Email
lucilla.parnetti@unipg.it

Spain

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
37
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Hospital San Pedro
Department Name
Neurology
Contact Person Name
María Eugenia Marzo Sola
Contact Person Email
memarzo@riojasalud.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Miguel Baquero Toledo
Contact Person Email
miquelbaquero@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology
Contact Person Name
Emilio Franco Macías
Contact Person Email
efranco17@gmail.com
Site Name
Hospital Victoria Eugenia De La Cruz Roja Espanola
Department Name
Neurology
Contact Person Name
Félix Viñuela
Contact Person Email
fvinuelaf@gmail.com
Site Name
Fundacio Ace Institut Catala De Neurociencies Aplicades
Department Name
Neurology
Contact Person Name
Mercè Boada Rovira
Contact Person Email
mboada@fundacioace.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurology
Contact Person Name
Alberto Villarejo Galende
Contact Person Email
avgalende@yahoo.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Juan Fortea
Contact Person Email
JFortea@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurology
Contact Person Name
Guillermo García Ribas
Contact Person Email
guille314@telefonica.net
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurology
Contact Person Name
Eloy Rodríguez Rodríguez
Contact Person Email
eloymrod@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
42
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Brain Research Center Den Bosch B.V.
Principal Investigator Name
Jort (E.G.B.) Vijverberg
Principal Investigator Email
start-up@brainresearchcenter.nl
Contact Person Name
Jort (E.G.B.) Vijverberg
Site Name
Brain Research Center Zwolle B.V.
Principal Investigator Name
Jort (E.G.B.) Vijverberg
Principal Investigator Email
start-up@brainresearchcenter.nl
Contact Person Name
Jort (E.G.B.) Vijverberg
Site Name
Amphia Hospital
Department Name
Neurology
Principal Investigator Name
Michel Remmers
Principal Investigator Email
researchneurologie@amphia.nl
Contact Person Name
Michel Remmers
Contact Person Email
researchneurologie@amphia.nl
Site Name
Brain Research Center Amsterdam B.V.
Principal Investigator Name
Jort (E.G.B.) Vijverberg
Principal Investigator Email
start-up@brainresearchcenter.nl
Contact Person Name
Jort (E.G.B.) Vijverberg

Poland

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
40
Number Of Sites
16
Number Of Participants
55

Sites

Site Name
Neuro-Care Sp. z o.o. sp.k.
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Katarzyna Binkowska-Michalik
Contact Person Email
pihouse@pihouse.pl
Site Name
NZOZ Wrocławskie Centrum Alzheimerowskie
Contact Person Name
Marzena Zboch
Contact Person Email
kontakt@alzheimer.wroclaw.pl
Site Name
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o.
Contact Person Name
Izabela Winel
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologii
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o. S.K.
Contact Person Name
Halina Bartosik-Psujek
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Agnieszka Adamczak-Ratajczak
Contact Person Email
kontakt@cr-center.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Neurologii Dorosłych
Contact Person Name
Bartosz Karaszewski
Contact Person Email
neurologia@uck.gda.pl
Site Name
Syberka-Clinhouse Sp. z o.o.
Contact Person Name
Klaudiusz Kumor
Contact Person Email
jakub.knysak@cmclinhouse.pl
Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Contact Person Name
Paweł Lisewski
Contact Person Email
cmneuromed@neuromed.com.pl
Site Name
Centrum Medyczne Senior
Department Name
Poradnia Psychogeriatryczna
Contact Person Name
Dorota Ussorowska
Contact Person Email
katarzyna.sobus@cmsenior.pl
Site Name
Podlaskie Centrum Psychogeriatrii
Contact Person Name
Jacek Dobryniewski
Contact Person Email
biuro@psychiatria.bialystok.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Psychiatrii Wieku Podeszłego i Zaburzeń Psychotycznych
Contact Person Name
Jakub Kaźmierski
Contact Person Email
jakub.kazmierski@umed.lodz.pl
Site Name
ProNeuro Centrum Medyczne
Contact Person Name
Ewa Krzystanek
Contact Person Email
biuro@proneuro.pl
Site Name
Etg Neuroscience Sp. z o.o.
Contact Person Name
Aleksandra Karbowniczek
Contact Person Email
neuroscience@etg-network.com
Site Name
Centrum Medyczne Neuroprotect
Contact Person Name
Mariusz Grudniak
Contact Person Email
recepcja@neuroprotect.pl

Germany

Earliest CTIS Part Ii Submission Date
12-10-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
96
Number Of Sites
29
Number Of Participants
40

Sites

Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Matthias Riemenschneider
Principal Investigator Email
Matthias.Riemenschneider@uks.eu
Contact Person Name
Matthias Riemenschneider
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma-Forschungs­zentrum (HRF)
Contact Person Name
Iska Steigemann
Contact Person Email
steigemann-studien@hotmail.com
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Experimental and Clinical Research Center (ECRC)
Principal Investigator Name
Julian Hellmann-Regen
Principal Investigator Email
julian.hellmann@charite.de
Contact Person Name
Julian Hellmann-Regen
Contact Person Email
julian.hellmann@charite.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Universitätsklinik für Neurologie
Principal Investigator Name
Emrah Düzel
Principal Investigator Email
emrah.duezel@med.ovgu.de
Contact Person Name
Emrah Düzel
Contact Person Email
emrah.duezel@med.ovgu.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Timo Grimmer
Principal Investigator Email
t.grimmer@tum.de
Contact Person Name
Timo Grimmer
Contact Person Email
t.grimmer@tum.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Neurologie/Gedächtnisambulanz
Principal Investigator Name
Dörte Polivka
Principal Investigator Email
doerte.polivka@uni-ulm.de
Contact Person Name
Dörte Polivka
Contact Person Email
doerte.polivka@uni-ulm.de
Site Name
Zentralinstitut Fuer Seelische Gesundheit
Department Name
ZI
Principal Investigator Name
Lucrezia Hausner
Principal Investigator Email
lucrezia.hausner@zi-mannheim.de
Contact Person Name
Lucrezia Hausner
Site Name
St. Josef-Hospital
Department Name
Klinik für Neurologie
Principal Investigator Name
Siegfried Muhlack
Principal Investigator Email
siegfried.muhlack@rub.de
Contact Person Name
Isigfried Muhlack
Contact Person Email
siegfried.muhlack@rub.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Neurologie und Neurophysiologie
Principal Investigator Name
Jonas Hosp
Principal Investigator Email
jonas.hosp@uniklinik-freiburg.de
Contact Person Name
Jonas Hosp
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Neurologie
Principal Investigator Name
Björn Falkenburger
Principal Investigator Email
bjoern.falkenburger@ukdd.de
Contact Person Name
Björn Falkenburger
Contact Person Email
bjoern.falkenburger@ukdd.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Kathrin Reetz
Principal Investigator Email
kreetz@ukaachen.de
Contact Person Name
Kathrin Reetz
Contact Person Email
kreetz@ukaachen.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Psychiatrische und Psychotherapeutische Klinik
Principal Investigator Name
Timo Oberstein
Principal Investigator Email
timo.oberstein@uk-erlangen.de
Contact Person Name
Timo Oberstein
Contact Person Email
timo.oberstein@uk-erlangen.de
Site Name
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Department Name
Praxis
Principal Investigator Name
Elvira Steidl
Principal Investigator Email
dr.steidl@forschung-badhomburg.de
Contact Person Name
Elvira Steidl
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Benjamin Franklin
Principal Investigator Name
Andreas Lüschow
Principal Investigator Email
andreas.lueschow@charite.de
Contact Person Name
Andreas Lüschow
Contact Person Email
andreas.lueschow@charite.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Neurologie mit Institut für Translationale Neurologie
Principal Investigator Name
Matthias Pawlowski
Principal Investigator Email
Matthias.Pawlowski@ukmuenster.de
Contact Person Name
Matthias Pawlowski
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Neurologie
Principal Investigator Name
Dorothee Saur
Principal Investigator Email
dorothee.saur@medizin.uni-leipzig.de
Contact Person Name
Dorothee Saur
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Thorsten Bartsch
Principal Investigator Email
thorsten.bartsch@uksh.de
Contact Person Name
Thorsten Bartsch
Contact Person Email
thorsten.bartsch@uksh.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Institut für Schlaganfall- und Demenzforschung (ISD)
Principal Investigator Name
Katharina Bürger
Principal Investigator Email
katharina.buerger@med.uni-muenchen.de
Contact Person Name
Katharina Bürger
Site Name
LMU Klinikum Muenchen AöR
Department Name
Neurologische Klinik und Poliklinik
Principal Investigator Name
Johannes Levin
Principal Investigator Email
johannes.levin@med.uni-muenchen.de
Contact Person Name
Johannes Levin
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Abteilung für Neurologie
Principal Investigator Name
Matthias Maschke
Principal Investigator Email
m.maschke@bk-trier.de
Contact Person Name
Matthias Maschke
Contact Person Email
m.maschke@bk-trier.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Matthias Schwab
Principal Investigator Email
matthias.schwab@med.uni-jena.de
Contact Person Name
Matthias Schwab
Site Name
Klinikum Bayreuth GmbH
Department Name
Klinik für Neurologie; Klinik Hohe Warte Bayreuth
Principal Investigator Name
Patrick Oschmann
Principal Investigator Email
patrick.oschmann@klinikum-bayreuth.de
Contact Person Name
Patrick Oschmann
Site Name
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Department Name
Klinik für Alterspsychiatrie und Kognitive Störungen
Principal Investigator Name
Klaus Fließbach
Principal Investigator Email
Klaus.Fliessbach@ukbonn.de
Contact Person Name
Klaus Fließbach
Contact Person Email
Klaus.Fliessbach@ukbonn.de
Site Name
Neuro Centrum Science GmbH
Department Name
Praxis
Principal Investigator Name
Rupert Knoblich
Principal Investigator Email
r.knoblich@neuro-centrum-science.de
Contact Person Name
Rupert Knoblich
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinikum Bremen-Ost
Principal Investigator Name
Thomas Duning
Principal Investigator Email
thomas.duning@gesundheitnord.de
Contact Person Name
Thomas Duning
Site Name
LMU Klinikum Muenchen AöR (Nussbaumstrasse 7)
Department Name
Klinik für Psychiatrie und Psychotherapie
Principal Investigator Name
Robert Perneczky
Principal Investigator Email
Robert.Perneczky@med.uni-muenchen.de
Contact Person Name
Robert Perneczky

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties include codes 1 and 4 (specific descriptions not provided in CTIS JSON)
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties code 4 (specific description not provided in CTIS JSON)
Name
Q Squared Solutions Limited
Responsibilities
sponsorDuties code 4 (specific description not provided in CTIS JSON)

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes present (e.g. code 1 and code 4) — specific duty descriptions not provided in CTIS JSON","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties code 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (The Alba Campus, Rosebank)","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Woodley Equipment Company Limited","duties_or_roles":"Equipment provider (sponsorDuties code 15; value: 'Equipment provider')","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"WCG Rater Training (sponsorDuties code 15; value: 'WCG Rater Training')","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Investigator meeting (sponsorDuties code 15; value: 'Investigator meeting')","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc. (MRI and PET)","duties_or_roles":"MRI and PET (sponsorDuties code 15; value: 'MRI and PET')","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS (sponsorDuties code 15; value: 'IxRS')","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG provider (sponsorDuties code 15; value: 'ECG provider')","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Trontinemab
Active Substance
TRONTINEMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Investigational Product Name
Placebo Trontinemab
Modality
Other
Investigational Product Name
[18F]MK-6240
Active Substance
FLORQUINITAU (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Investigational Product Name
Amyvid 800/1900 MBq/mL solution for injection
Active Substance
FLORBETAPIR (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Marketing authorisation exists for Amyvid (prodAuthStatus values present)
Maximum Dose
1110 MBq (max total amount listed for some products)
Investigational Product Name
VIZAMYL 400 MBq/mL solution for injection
Active Substance
FLUTEMETAMOL (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Marketing authorisation exists (prodAuthStatus 2 recorded)
Maximum Dose
555 MBq (max total amount listed)
Investigational Product Name
Neuraceq 300 MBq/mL solution for injection
Active Substance
FLORBETABEN (18F)
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Marketing authorisation exists (prodAuthStatus 2 recorded)
Maximum Dose
900 MBq (max total amount listed)

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