Clinical trial • Phase III • Neurology

TRONTINEMAB for Alzheimer's disease | Mild cognitive impairment (MCI) | Mild dementia due to Alzheimer's disease

Phase III trial of TRONTINEMAB for Alzheimer's disease | Mild cognitive impairment (MCI) | Mild dementia due to Alzheimer's disease.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Alzheimer's disease | Mild cognitive impairment (MCI) | Mild dementia due to Alzheimer's disease
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, placebo trontinemab (placebo arm) versus trontinemab (active arm); dose and dosing schedule not specified in ctis record.-controlled Phase III trial across 85 sites in Denmark, Italy, Spain and others.

Randomised
Yes
Comparator
Placebo Trontinemab (placebo arm) versus Trontinemab (active arm); dose and dosing schedule not specified in CTIS record.
Target Sample Size
535
Trial Duration For Participant
504

Eligibility

Recruits 535 Vulnerable population selected: participants with cognitive impairment (Early Symptomatic Alzheimer’s Disease). The protocol requires availability of an appropriate study partner (inclusion criterion). Subject information and informed consent materials include participant, caregiver and study partner informed consent forms (documents listed: L1_SIS and ICF Main, L1_ICF Caregiver, L1_SIS and ICF STUDY PARTNER, etc.), indicating involvement of study partners/caregivers in consent processes where applicable..

Vulnerable Population
Vulnerable population selected: participants with cognitive impairment (Early Symptomatic Alzheimer’s Disease). The protocol requires availability of an appropriate study partner (inclusion criterion). Subject information and informed consent materials include participant, caregiver and study partner informed consent forms (documents listed: L1_SIS and ICF Main, L1_ICF Caregiver, L1_SIS and ICF STUDY PARTNER, etc.), indicating involvement of study partners/caregivers in consent processes where applicable.

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 to Week 72 measured by the Clinical Dementia Rating, Sum of Boxes (CDR-SB) score (baseline vs Week 72)."}

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 in 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 in 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 in iADRS score."}
  • {"endpoint_text":"- Change from baseline through Week 72 in: ▪ MMSE","definition_or_measurement_approach":"Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) score."}
  • {"endpoint_text":"- Time to increase in CDR-GS","definition_or_measurement_approach":"Time-to-event analysis measuring time to increase in Clinical Dementia Rating, Global Score (CDR-GS)."}
  • {"endpoint_text":"- Nature, frequency, severity of adverse event (AEs) and serious adverse event (SAEs)","definition_or_measurement_approach":"Collection and descriptive analysis of safety events (type, frequency, severity) including AEs and SAEs throughout the study."}
  • {"endpoint_text":"- Change from baseline in clinical laboratory assessments and vital signs, physical examinations (including neurological systems), Electrocardiogram (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Change from baseline in clinical labs, vital signs, physical/neurological exams, ECGs, and C-SSRS assessments."}
  • {"endpoint_text":"- Nature, frequency, severity, and timing of ARIA-E and ARIA-H MRI findings","definition_or_measurement_approach":"MRI-detected ARIA-E and ARIA-H events characterized by nature, frequency, severity and timing."}
  • {"endpoint_text":"- Nature, frequency, severity, and timing of Infusion-related reactions (IRRs)","definition_or_measurement_approach":"Collection and characterization of infusion-related reactions (IRRs) by nature, frequency, severity and timing."}
  • {"endpoint_text":"- Incidence and titer of anti-drug antibody (ADAs) to trontinemab during the study relative to the prevalence of ADAs at baseline","definition_or_measurement_approach":"Measurement of ADA incidence and titers during study compared to 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":"Change from baseline to Week 72 in brain amyloid load as measured by amyloid PET imaging."}
  • {"endpoint_text":"- Change from baseline to Week 72 in brain tau load, as measured by tau PET scan in a subset of participants","definition_or_measurement_approach":"Change from baseline to Week 72 in brain tau load measured by tau PET in a subset."}
  • {"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":"Change from baseline through Week 72 in CSF biomarkers (p-tau181, Neurogranin, Aβ42) in a subset."}
  • {"endpoint_text":"- Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)","definition_or_measurement_approach":"Change from baseline through Week 72 in blood biomarkers p-tau217 and GFAP."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include online banners, social media support/posts, QR codes and digital banners as listed in recruitment documents (e.g., Online banner V1, Social media support, QR code roll-ups).
Planned Sample Size
535
Recruitment Window Months
30
Consent Approach
Informed consent obtained using participant information sheets and informed consent forms. Separate ICFs and supporting materials exist for participants, caregivers and study partners (documents listed: L1_SIS and ICF Main, L1_ICF Caregiver, L1_SIS and ICF STUDY PARTNER, L1_SIS and ICF Participant, L1_SIS and ICF Partner). Materials include IAF, privacy/ GDPR appendices and APOE result explainer booklets. Consent materials are provided in multiple languages (document synopses and ICF files available in English, French, German, Italian, Spanish, Polish as evidenced by file list with language-specific synopses and recruitment materials). Consent is provided by the participant; study partner/caregiver involvement is supported by dedicated study partner/caregiver ICFs.

Methods

  • Flyers and printed posters distributed at clinical sites and local institutions (country-specific flyers/posters documented, e.g., K2_Recruitment material_Trontier 1_Flyer_DE_WN45443 and corresponding poster documents).
  • Online banners and QR-code enabled roll-up/advertisements (documents: K2_Recruitment material_Trontier 1_Online banner V1_DE_WN45443; Roche_Alzheimer_RollUp QR_Code documents).
  • Social media support and social media posts (documents: K2_Recruitment material_Social media support_ES / CAT; K3_Recruitment material Social Media posts).
  • Recruitment leaflets and patient cards (K2_Recruitment material Flyer, K4_Patient card).
  • Inclusive research guides and support materials for recruitment (K2_Inclusive Research Guide, Inclusive research guide translations).
  • Site-level recruitment arrangements and placeholders (K1_Recruitment arrangements documents per country).

Geography

Total Number Of Sites
85
Total Number Of Participants
265

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
7

Sites

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
Site Name
Rigshospitalet
Department Name
Hukommelsesklinikken
Contact Person Name
Kristian Steen Frederiksen

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
50

Sites

Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Departement of Biomedical, Metabolic and Neural Sciences
Contact Person Name
Giovanna Zamboni
Contact Person Email
giovanna.zamboni@unimore.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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Neurologia
Contact Person Name
Camillo Marra
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
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
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
Fondazione Santa Lucia
Department Name
Neurologia e Riabilitazione Neurologica
Contact Person Name
Giacomo Koch
Contact Person Email
g.koch@hsantalucia.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Neurology
Contact Person Name
Fulvio Da Re
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
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
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
Ospedale Isola Tiberina Gemelli Isola
Department Name
Neurologia
Contact Person Name
Emanuele Cassetta
Contact Person Email
emanuele.cassetta@afar.it

Spain

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
39
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
Hospital Universitari De Santa Maria
Department Name
Neurology
Contact Person Name
Gerard Piñol Ripoll
Contact Person Email
gpinol@gss.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Pilar Delgado Martínez
Contact Person Email
mpilar.delgado@vallhebron.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurology
Contact Person Name
Rafael Arroyo
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Universitari General De Catalunya
Department Name
Neurology
Contact Person Name
Ernest Balaguer Martínez
Contact Person Email
ebalaguer@quironsalud.es
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology
Contact Person Name
María Teresa Carreras Rodríguez
Contact Person Email
maitecarreras@gmail.com
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurology
Contact Person Name
Lamperto Landete Pascual
Site Name
Hospital Universitario Reina Sofia
Department Name
Neurology
Contact Person Name
Eduardo Agüera
Contact Person Email
Doctoredu@gmail.com
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Neurology
Contact Person Name
Jerzy Krupinski
Contact Person Email
jkrupinski@mutuaterrassa.es
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurology
Contact Person Name
Gurutz Linazasoro Cristobal
Contact Person Email
glinazasoro@telefonica.net

Poland

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
35
Number Of Sites
13
Number Of Participants
70

Sites

Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Neurologiczny
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
neurozab@sum.edu.pl
Site Name
Syberka-Clinhouse Sp. z o.o.
Contact Person Name
Klaudiusz Kumor
Contact Person Email
jakub.knysak@cmclinhouse.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
Etg Neuroscience Sp. z o.o.
Contact Person Name
Aleksandra Karbowniczek
Contact Person Email
neuroscience@etg-network.com
Site Name
Nmedis Sp. z o.o.
Contact Person Name
Iwona Rościszewska-Żukowska
Contact Person Email
badaniakliniczne@nmedis.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Department Name
Centrum Neurologii Klinicznej
Contact Person Name
Monika Rudzińska-Bar
Site Name
Podlaskie Centrum Psychogeriatrii
Contact Person Name
Jacek Dobryniewski
Contact Person Email
biuro@psychiatria.bialystok.pl
Site Name
Centrum Medyczne Senior
Department Name
Poradnia Psychogeriatryczna
Contact Person Name
Dorota Ussorowska
Contact Person Email
katarzyna.sobus@cmsenior.pl
Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Contact Person Name
Paweł Lisewski
Contact Person Email
cmneuromed@neuromed.com.pl
Site Name
Neuro-Care Sp. z o.o. sp.k.
Department Name
Neuro-Care Centrum Medyczne Katowice
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl
Site Name
NZOZ Wrocławskie Centrum Alzheimerowskie
Contact Person Name
Marzena Zboch
Contact Person Email
kontakt@alzheimer.wroclaw.pl
Site Name
Affidea Centrum Leczenia Zaburzeń Pamięci
Contact Person Name
Jacek Staszewski
Contact Person Email
Iga.jagodzinska@affidea.com
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Contact Person Name
Anna Jamroz-Wiśniewska

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
18
Number Of Participants
38

Sites

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 Regional De Marseille
Department Name
Hôpital de la Timone
Contact Person Name
Mathieu Ceccaldi
Contact Person Email
mathieu.ceccaldi@ap-hm.fr
Site Name
CHRU De Nancy
Department Name
Hôpitaux de Brabois
Contact Person Name
Laure Joly
Contact Person Email
l.joly@chru-nancy.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 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 Bordeaux
Department Name
Hôpital Pellegrin
Contact Person Name
Vincent Planche
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
Centre Hospitalier Universitaire De Nantes
Department Name
Hôpital Laennec
Contact Person Name
Claire Boutoleau-Bretonnière
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 Et Universitaire De Limoges
Department Name
Hôpital Dupuytren
Contact Person Name
Achille Tchalla
Contact Person Email
achille.tchalla@chu-limoges
Site Name
Hospices Civils De Lyon (Bron)
Department Name
Hôpital neurologique Pierre Wertheimer
Contact Person Name
Hélène Mollion
Contact Person Email
helene.mollion@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hôpital Pontchaillou
Contact Person Name
Cezara-Roxona Hanta
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
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
Centre Hospitalier Universitaire De Lille
Department Name
Hôpital Roger Salengro
Contact Person Name
Marie-Anne Mackowiak
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
CHU Amiens
Contact Person Name
Olivier Godefroy
Site Name
Assistance Publique Hopitaux De Paris (Broca)
Department Name
Hôpital Broca
Contact Person Name
Hermine Lenoir
Contact Person Email
hermine.lenoir@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (La pitié Salpêtrière)
Department Name
Hôpital La pitié Salpêtrière
Contact Person Name
Nicolas Villain
Contact Person Email
nicolas.villain@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
26
Number Of Sites
30
Number Of Participants
50

Sites

Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Abteilung für Neurologie
Contact Person Name
Matthias Maschke
Contact Person Email
m.maschke@bk-trier.de
Site Name
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Department Name
Praxis
Contact Person Name
Elvira Steidl
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Psychiatrie und Psychotherapie
Contact Person Name
Matthias Riemenschneider
Site Name
St. Josef-Hospital
Department Name
Klinik für Neurologie
Contact Person Name
Siegfried Muhlack
Contact Person Email
siegfried.muhlack@rub.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Klinikum Bremen-Ost
Contact Person Name
Thomas Duning
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Psychiatrie und Psychotherapie
Contact Person Name
Jens Wiltfang
Site Name
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Department Name
Klinik für Alterspsychiatrie und Kognitive Störungen
Contact Person Name
Klaus Fließbach
Contact Person Email
Klaus.Fliessbach@ukbonn.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Neurologie
Contact Person Name
Kathrin Reetz
Contact Person Email
kreetz@ukaachen.de
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
Universitaetsklinikum Magdeburg AöR
Department Name
Universitätsklinik für Neurologie
Contact Person Name
Emrah Düzel
Contact Person Email
emrah.duezel@med.ovgu.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Neurologie
Contact Person Name
Thorsten Bartsch
Contact Person Email
thorsten.bartsch@uksh.de
Site Name
Neuropraxis München Süd
Department Name
Praxis
Contact Person Name
Ralf Kubalek
Site Name
Universitaetsklinikum Goettingen (duplicate listed as separate entry)
Department Name
Klinik für Psychiatrie und Psychotherapie
Contact Person Name
Jens Wiltfang
Site Name
Charite Universitaetsmedizin Berlin KöR (ECRC)
Department Name
Experimental and Clinical Research Center (ECRC)
Contact Person Name
Julian Hellmann-Regen
Contact Person Email
julian.hellmann@charite.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Institut für Schlaganfall- und Demenzforschung (ISD)
Contact Person Name
Katharina Bürger
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Psychiatrische und Psychotherapeutische Klinik
Contact Person Name
Timo Oberstein
Contact Person Email
timo.oberstein@uk-erlangen.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Neurologie
Contact Person Name
Matthias Schwab
Site Name
Zentralinstitut Fuer Seelische Gesundheit
Department Name
ZI
Contact Person Name
Lucrezia Hausner
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Björn Falkenburger
Contact Person Email
bjoern.falkenburger@ukdd.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Contact Person Name
Franziska Maier
Contact Person Email
franziska.maier@uk-koeln.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Benjamin Franklin)
Department Name
Campus Benjamin Franklin
Contact Person Name
Andreas Lüschow
Contact Person Email
andreas.lueschow@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Neurologie/Gedächtnisambulanz
Contact Person Name
Dörte Polivka
Contact Person Email
doerte.polivka@uni-ulm.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Neurologie und Neurophysiologie
Contact Person Name
Jonas Hosp
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Neurologie mit Institut für Translationale Neurologie
Contact Person Name
Matthias Pawlowski
Site Name
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
Department Name
Neurologie Berlin
Contact Person Name
Marie Perle Brinckmann
Site Name
Neuro Centrum Science GmbH
Department Name
Praxis
Contact Person Name
Rupert Knoblich
Site Name
LMU Klinikum Muenchen AöR (Marchioninistrasse)
Department Name
Neurologische Klinik und Poliklinik
Contact Person Name
Johannes Levin
Site Name
Klinikum Bayreuth GmbH
Department Name
Klinik für Neurologie; Klinik Hohe Warte Bayreuth
Contact Person Name
Patrick Oschmann
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik für Psychiatrie und Psychotherapie
Contact Person Name
Timo Grimmer
Contact Person Email
t.grimmer@tum.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Dorothee Saur
Site Name
Ludwig-Maximilians-Universitaet Muenchen
Department Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie
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
Central Laboratory Provider; Site Management Provider, Monitoring; central lab services applicable to multiple regions
Name
Bioclinica Inc.
Responsibilities
Central Imaging Provider (MRI and PET); WCG-Rater Training
Name
Pharmaceutical Product Development LLC
Responsibilities
Analytical laboratory services
Name
Eresearchtechnology Inc. (Clario)
Responsibilities
ECG Provider
Name
4g Clinical LLC
Responsibilities
IxRS Provider

Third parties

  • {"country":"United Kingdom","full_name":"Woodley Equipment Company Limited","duties_or_roles":"Non-Clinical Supply Provider, Equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory Provider, Applicable to EU, Switzerland and UK; Site Management Provider, Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"WCG-Rater Training; Central Imaging Provider, MRI and PET","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Investigator Meeting","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc. (second entry)","duties_or_roles":"Central Imaging Provider, MRI and PET","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory Provider, Applicable for EU, UK, APAC, Japan and China","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Analytical Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG Provider, Clario (ECG Provider)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (site management entry)","duties_or_roles":"Site Management Provider, Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS Provider","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Trontinemab
Active Substance
TRONTINEMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Not authorised
Investigational Product Name
Placebo Trontinemab
Modality
Other
Investigational Product Name
Amyvid 800 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
Authorised
Starting Dose
Up to 370 MBq per day (max daily dose amount 370 MBq, max total dose amount 1110 MBq noted in product entry)
Frequency
Single administration (maxTreatmentPeriod: 1)
Maximum Dose
1110 MBq (max total dose amount as listed)
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
Authorised
Starting Dose
Up to 185 MBq per day (max daily dose amount 185 MBq, max total dose 555 MBq noted)
Frequency
Single administration (maxTreatmentPeriod: 1)
Maximum Dose
555 MBq
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
Authorisation Status
Not authorised
Frequency
Single administration (maxTreatmentPeriod: 1)
Investigational Product Name
Amyvid 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
Authorised
Starting Dose
Up to 370 MBq per day (maxDailyDoseAmount 370 MBq, maxTotalDoseAmount 1110 MBq listed)
Frequency
Single administration (maxTreatmentPeriod: 1)
Maximum Dose
1110 MBq
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
Authorised
Starting Dose
Up to 300 MBq per day (maxDailyDoseAmount 300 MBq, maxTotalDoseAmount 900 MBq listed)
Frequency
Single administration (maxTreatmentPeriod: 1)
Maximum Dose
900 MBq

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