An Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

Start 13 Nov 2025 · Status Authorised, recruiting · 6 EU/EEA countries · 85 sites · Protocol WN45443

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruiting

Participants planned 800

Countries 6

Sites 85

Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

To evaluate the effect of trontinemab on clinical progression at Week 72 as compared with placebo

Key facts

Sponsor: F. Hoffmann-La Roche AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trial duration: 13 Nov 2025 → ongoing
Decision date (initial): 2025-11-04
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Others, Efficacy

To evaluate the effect of trontinemab on clinical progression at Week 72 as compared with placebo

Secondary objectives 4

To evaluate the efficacy of trontinemab compared with placebo on clinical progression
To evaluate the efficacy of trontinemab compared with placebo on time to clinical progression
To evaluate the safety of trontinemab compared with placebo
To evaluate the pharmacodynamic effect of trontinemab compared with placebo

Conditions and MedDRA coding

Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

Version	Level	Code	Term	System organ class
20.0	LLT	10001896	Alzheimer's disease	10029205

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
Plan to share IPD: No
IPD plan description: N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 6

Any evidence of a condition other than AD that may affect cognition
Inability to tolerate MRI procedures or contraindication to MRI
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
History or presence of clinically significant cerebrovascular disease
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
History of hypersensitivity to biologic agents or any of the excipients in the formulation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Secondary endpoints 14

Change from baseline through Week 72 in: ▪ Alzheimer’s Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
Change from baseline through Week 72 in: ▪ Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score
Change from baseline through Week 72 in: ▪ Integrated Alzheimer’s Disease Rating Scale (iADRS)
Change from baseline through Week 72 in: ▪ MMSE
Time to increase in CDR-GS
Nature, frequency, severity of adverse event (AEs) and serious adverse event (SAEs)
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)
Nature, frequency, severity, and timing of ARIA-E and ARIA-H MRI findings
Nature, frequency, severity, and timing of Infusion-related reactions (IRRs)
Incidence and titer of anti-drug antibody (ADAs) to trontinemab during the study relative to the prevalence of ADAs at baseline
Change from baseline through Week 72 in brain amyloid load, as measured by amyloid positron emission tomography (PET) scan
Change from baseline to Week 72 in brain tau load, as measured by tau PET scan in a subset of participants
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
Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Trontinemab

PRD10948805 · Product

Active substance: Trontinemab
Substance synonyms: RO-7126209
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: IV INFUSION
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Not Authorised
MA holder: F. HOFFMANN-LA ROCHE LTD
Paediatric formulation: No
Orphan designation: No

Placebo 1

Placebo Trontinemab

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 7

VIZAMYL 400 MBq/mL solution for injection

PRD10888598 · Product

Active substance: Flutemetamol (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 185 MBq megabecquerel(s)
Max total dose: 555 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX04 — -
Marketing authorisation: EU/1/14/941/001
MA holder: GE HEALTHCARE AS
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Different manufacturing

Neuraceq 300 MBq/mL solution for injection

PRD10894409 · Product

Active substance: Florbetaben (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 300 MBq megabecquerel(s)
Max total dose: 900 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX06 — -
Marketing authorisation: EU/1/13/906/001
MA holder: LIFE MOLECULAR IMAGING GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

[18F]MK-6240

PRD12459635 · Product

Active substance: Florquinitau (18F)
Substance synonyms: Florquinitau F18, [18F] MK-6240
Other product name: florquinitau F-18
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Not Authorised
MA holder: F. HOFFMANN-LA ROCHE LTD
Paediatric formulation: No
Orphan designation: No

Amyvid 1900 MBq/mL solution for injection

PRD2433351 · Product

Active substance: Florbetapir (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 370 MBq megabecquerel(s)
Max total dose: 1110 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX05 — -
Marketing authorisation: EU/1/12/805/004
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amyvid 800 MBq/mL solution for injection

PRD2433277 · Product

Active substance: Florbetapir (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 370 MBq megabecquerel(s)
Max total dose: 1110 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX05 — -
Marketing authorisation: EU/1/12/805/002
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amyvid 1900 MBq/mL solution for injection

PRD2433313 · Product

Active substance: Florbetapir (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 370 MBq megabecquerel(s)
Max total dose: 1110 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX05 — -
Marketing authorisation: EU/1/12/805/003
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amyvid 800 MBq/mL solution for injection

PRD2426694 · Product

Active substance: Florbetapir (18F)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 370 MBq megabecquerel(s)
Max total dose: 1110 MBq megabecquerel(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: V09AX05 — -
Marketing authorisation: EU/1/12/805/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation: F. Hoffmann-La Roche AG
Address: Grenzacherstrasse 124
City: Basel
Postcode: 4058
Country: Switzerland

Scientific contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Public contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Third parties 10

Organisation	City, country	Duties
Woodley Equipment Company Limited ORG-100043990	Bolton, United Kingdom	Other
IQVIA Limited ORG-100008655	Livingston, United Kingdom	Other
Bioclinica Inc. ORG-100033079	Philadelphia, United States	Other
Q2q Communications Limited ORG-100041455	Richmond, United Kingdom	Other
Bioclinica Inc. ORG-100033079	Philadelphia, United States	Other
Q Squared Solutions Limited ORG-100042527	Reading, United Kingdom	Other
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other
Eresearchtechnology Inc. ORG-100013039	Philadelphia, United States	Other
IQVIA Limited ORG-100008655	Reading, United Kingdom	Other
4g Clinical LLC ORG-100042775	Wellesley, United States	Other

Locations

6 EU/EEA countries · 85 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ended	7	3
France	Ongoing, recruiting	38	18
Germany	Ongoing, recruiting	50	30
Italy	Ongoing, recruiting	50	12
Poland	Ongoing, recruiting	70	13
Spain	Ongoing, recruiting	50	9
Rest of world Taiwan, Canada, Brazil, Japan, United States, Argentina, United Kingdom	—	535	—

Investigational sites

Denmark

3 sites · Ended

Region Midtjylland

Neurologisk forskning, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Aalborg University Hospital

Neurologisk Afdeling, Demensenheden, Ladegaardsgade 5, 9000, Aalborg

Rigshospitalet

Hukommelsesklinikken, Inge Lehmanns Vej 7, 2100, Copenhagen Oe

France

18 sites · Ongoing, recruiting

Hospices Civils De Lyon

Hôpital des Charpennes, 27 Rue Gabriel Peri, 69100, Villeurbanne

Centre Hospitalier Universitaire De Montpellier

Hôpital Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

CHRU De Nancy

Hôpitaux de Brabois, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex

Centre Hospitalier Universitaire De Toulouse

Hôpital la Grave, 9 Place Lange, 31300, Toulouse

Assistance Publique Hopitaux De Paris

Hôpital Broca, 54 56 Rue Pascal 54a, 75013, Paris

Centre Hospitalier Universitaire De Lille

Hôpital Roger Salengro, Rue Emile Laine, 59037, Lille Cedex

Centre Hospitalier Universitaire Amiens Picardie

CHU Amiens, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1

Assistance Publique Hopitaux De Paris

Hôpital Lariboisière Fernand-Widal, 2 Rue Ambroise Pare, 75010, Paris

Centre Hospitalier Universitaire De Rennes

Hôpital Pontchaillou, 2 Rue Henri Le Guilloux, 35000, Rennes

Centre Hospitalier Regional Universitaire De Tours

Hôpital Bretonneau, 2 Boulevard Tonnelle, 37000, Tours

Centre Hospitalier Regional De Marseille

Hôpital de la Timone, 264 Rue Saint Pierre, 13005, Marseille

Centre Hospitalier Et Universitaire De Limoges

Hôpital Dupuytren, 2 Avenue Martin Luther King, 87000, Limoges

Hospices Civils De Lyon

Hôpital neurologique Pierre Wertheimer, 59 Boulevard Pinel, 69500, Bron

Centre Hospitalier Universitaire De Bordeaux

Hôpital Pellegrin, Place Amelie Raba Leon, 33000, Bordeaux

Les Hopitaux Universitaires De Strasbourg

Hôpital de la Robertsau, 21 Rue David Richard, 67000, Strasbourg

Assistance Publique Hopitaux De Paris

Hôpital La pitié Salpêtrière, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris

Centre Hospitalier Universitaire Rouen

Hôpital Charles Nicolle, 1 Rue De Germont, Bp 96031, Rouen Cedex

Centre Hospitalier Universitaire De Nantes

Hôpital Laennec, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain

Germany

30 sites · Ongoing, recruiting

Universitaetsklinikum Jena KöR

Klinik für Neurologie, Am Klinikum 1, Lobeda, Jena

Universitaetsmedizin Goettingen

Klinik für Psychiatrie und Psychotherapie, Von-Siebold-Strasse 5, 37075, Goettingen

Universitaetsklinikum Aachen AöR

Klinik für Neurologie, Pauwelsstrasse 30, 52074, Aachen

LMU Klinikum Muenchen AöR

Institut für Schlaganfall- und Demenzforschung (ISD), Feodor-Lynen-Strasse 17, Hadern, Munich

Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

Neurologie Berlin, Schloßstraße 29, 12163, Berlin

University Hospital Cologne AöR

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Kerpener Strasse 62, Lindenthal, Cologne

Universitaetsklinikum Schleswig-Holstein AöR

Klinik für Neurologie, Arnold-Heller-Strasse 3, Brunswik, Kiel

Universitaetsklinikum Magdeburg AöR

Universitätsklinik für Neurologie, Leipziger Strasse 44, 39120, Magdeburg

LMU Klinikum Muenchen AöR

Neurologische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich

Zentrum fuer klinische Forschung Dr. I. Schoell GmbH

Praxis, Hessenring 121, 61348, Bad Homburg

Neuropraxis München Süd

Praxis, Hauptstraße 2, 82008, Unterhaching

St. Josef-Hospital

Klinik für Neurologie, Gudrunstrasse 56, Grumme, Bochum

Gesundheit Nord gGmbH Klinikverbund Bremen

Klinikum Bremen-Ost, Zuericher Strasse 40, Ellenerbrok-Schevemoor, Bremen

Universitaetsklinikum Erlangen AöR

Psychiatrische und Psychotherapeutische Klinik, Schwabachanlage 6, Innenstadt, Erlangen

Zentralinstitut Fuer Seelische Gesundheit

ZI, Luisenring J 5, 68159, Mannheim

Universitaet Des Saarlandes

Klinik für Psychiatrie und Psychotherapie, Kirrberger Strasse 100, 66421, Homburg

Universitaetsklinikum Ulm AöR

Klinik für Neurologie/Gedächtnisambulanz, Oberer Eselsberg 45, Eselsberg, Ulm

Medical Center - University Of Freiburg

Klinik für Neurologie und Neurophysiologie, Breisacher Strasse 64, Stuehlinger, Freiburg Im Breisgau

Charite Universitaetsmedizin Berlin KöR

Campus Benjamin Franklin, Hindenburgdamm 30, Lichterfelde, Berlin

Universitaetsklinikum Muenster AöR

Klinik für Neurologie mit Institut für Translationale Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster

Neuro Centrum Science GmbH

Praxis, Albert-Schweitzer-Strasse 8, 64711, Erbach

Barmherzige Brueder Trier gGmbH

Abteilung für Neurologie, Nordallee 1, Trier-Nord, Trier

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH

Hamburger Rheuma-Forschungszentrum (HRF), Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg

Universitaet Leipzig

Klinik und Poliklinik für Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig

Klinikum Bayreuth GmbH

Klinik für Neurologie; Klinik Hohe Warte Bayreuth, Hohe Warte 8, Gruener Baum, Bayreuth

Charite Universitaetsmedizin Berlin KöR

Experimental and Clinical Research Center (ECRC), Lindenberger Weg 80, Buch, Berlin

Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.

Klinik für Alterspsychiatrie und Kognitive Störungen, Venusberg-Campus 1/99, Venusberg, Bonn

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Klinik für Psychiatrie und Psychotherapie, Ismaninger Strasse 22, Au-Haidhausen, Munich

Ludwig-Maximilians-Universitaet Muenchen

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Nussbaumstrasse 7, Ludwigsvorstadt-Isarvorstadt, Munich

Italy

12 sites · Ongoing, recruiting

Hospital Santa Maria Della Misericordia

Section of Neurology Dept. of Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia

Ospedale San Raffaele S.r.l.

U.O Neurologia, Via Olgettina 60, 20132, Milan

Azienda Ospedaliera Universitaria Federico II Di Napoli

Department of Neuroscience, Reproductivity Science and Odontostomatology, Via Sergio Pansini 5, 80131, Naples

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Dept. of Human Neurosciences - DAI Neuroscienze/Salute Mentale, Viale Del Policlinico 155, 00161, Rome

Fondazione IRCCS San Gerardo Dei Tintori

S.C. Neurology, Via Giovanni Battista Pergolesi 33, 20900, Monza

Pia Fondazione Di Culto E Religione Card G Panico

UOC Malattie Neurodegenerative, Via Pio X 4, 73039, Tricase

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

UOC Neurologia, Largo Francesco Vito 1, 00168, Rome

IRCCS Ospedale Policlinico San Martino

Neurology, Largo Rosanna Benzi 10, 16132, Genoa

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

S.C. Neurologia, Piazzale Spedali Civili 1, 25123, Brescia

Ospedale Isola Tiberina Gemelli Isola

Neurologia, Via Di Ponte Quattro Capi 39, 00186, Rome

Fondazione Santa Lucia

Neurologia e Riabilitazione Neurologica, Via Ardeatina 306, 00179, Rome

Azienda Ospedaliero Universitaria Di Modena

Departement of Biomedical, Metabolic and Neural Sciences, Largo Del Pozzo 71, 41124, Modena

Poland

13 sites · Ongoing, recruiting

Affidea Centrum Leczenia Zaburzeń Pamięci

n/a, ul. Grochowska 312, 03-480, Warszawa

Centrum Medyczne Neuromed Sp. z o.o.

n/a, Ul. Jana Biziela 14, 85-163, Bydgoszcz

Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak

n/a, Ul. 1 Maja 14, 20-410, Lublin

Centrum Badan Klinicznych Pi-House Sp. z o.o.

n/a, Ul. Na Zaspe 3, 80-546, Gdansk

Syberka-Clinhouse Sp. z o.o.

n/a, Ul. Zwyciestwa 30, 42-500, Bedzin

Krakowska Akademia Neurologii Sp. z o.o.

Centrum Neurologii Klinicznej, Ul. Arianska 7/3, 31-505, Cracow

NZOZ Wrocławskie Centrum Alzheimerowskie

n/a, Al. Gen. Władysława Sikorskiego 7/GHJ, 53-659, Wrocław

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach

Oddział Neurologiczny, Ul. 3 Maja 13/15, 41-800, Zabrze

Etg Neuroscience Sp. z o.o.

n/a, Ul. Wynalazek 4, 02-677, Warsaw

Centrum Medyczne Senior

Poradnia Psychogeriatryczna, Ul. Rzemieslnicza 3, 81-855, Sopot

Nmedis Sp. z o.o.

n/a, Ul. Kujawska 5, 35-323, Rzeszow

Podlaskie Centrum Psychogeriatrii

n/a, ul. Swobodna 38, 15-756, Białystok

Neuro-Care Sp. z o.o. sp.k.

Neuro-Care Centrum Medyczne Katowice, Ul. Pawla Kolodzieja 8, 40-749, Katowice

Spain

9 sites · Ongoing, recruiting

Hospital Universitari General De Catalunya

Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles

Hospital Universitario Reina Sofia

Neurology, Avenida Menendez Pidal S/n, 14004, Cordoba

Hospital Universitario De La Princesa

Neurology, Calle De Diego De Leon 62, 28006, Madrid

Policlinica Gipuzkoa S.A.

Neurology, Paseo Miramon 174, 20009, Donostia

Hospital Universitario Dr Peset Aleixandre

Neurology, Avinguda De Gaspar Aguilar 90, 46017, Valencia

Hospital Universitari Vall D Hebron

Neurology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Fundacio Assistencial De Mutua De Terrassa Fpc

Neurology, Calle De San Antonio No 32, 08221, Terrassa

Hospital Universitari De Santa Maria

Neurology, Av Alcalde Rovira Roure 44, 25198, Lleida

Hospital Universitario Quironsalud Madrid

Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
France	2025-11-13	2025-11-14
Germany	2025-11-18	2025-11-18
Italy	2025-12-12	2025-12-22
Poland	2025-11-18	2025-11-24
Spain	2025-11-14	2025-11-25

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 81 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	d1_protocol-2024-518006-40-00-redacted	1 EEA only
Protocol (for publication)	d4_patient-facing-documents_redaction-memo	3
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	3
Recruitment arrangements (for publication)	K1_Recruitment and Informed consent procedure	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_WN45443	1
Recruitment arrangements (for publication)	K2_D and I Leaflet	2
Recruitment arrangements (for publication)	K2_Document_additionnel redacted	1
Recruitment arrangements (for publication)	K2_Inclusive Research Guide	1
Recruitment arrangements (for publication)	K2_Recruitment material Flyer	1
Recruitment arrangements (for publication)	K2_Recruitment material Placeholder	1
Recruitment arrangements (for publication)	K2_Recruitment material Poster	1
Recruitment arrangements (for publication)	K2_Recruitment material_ Inclusive research guide_CAT	1
Recruitment arrangements (for publication)	K2_Recruitment material_ Inclusive research guide_ES	1
Recruitment arrangements (for publication)	K2_Recruitment material_Social media support_CAT	1
Recruitment arrangements (for publication)	K2_Recruitment material_Social media support_ES	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trontier 1_Flyer_DE_WN45443	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trontier 1_Inclusive Research Guide_DE_WN45443	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trontier 1_Online banner V1_DE_WN45443	2
Recruitment arrangements (for publication)	K2_Recruitment material_Trontier 1_Poster_DE_WN45443	1
Recruitment arrangements (for publication)	K2_Recruitment materials_Placeholder	1
Recruitment arrangements (for publication)	K2_Recruitment materials_Placeholder ICF script	1
Recruitment arrangements (for publication)	K2_Recrutiment material_Flyer_CAT	1
Recruitment arrangements (for publication)	K2_Recrutiment material_Flyer_ES	1
Recruitment arrangements (for publication)	K2_Recrutiment material_Poster_CAT	1
Recruitment arrangements (for publication)	K2_Recrutiment material_Poster_ES	1
Recruitment arrangements (for publication)	K2_Roche_Alzheimer_RollUp QR_Code 1_WN45443	1
Recruitment arrangements (for publication)	K2_Roche_Alzheimer_RollUp QR_Code 2_WN4544_	1
Recruitment arrangements (for publication)	K2_WN45443_Recruitment materials_Placeholder	1
Recruitment arrangements (for publication)	K3_Recruitment material Social Media posts	1
Recruitment arrangements (for publication)	K3_Recruitment materials_Placeholder	1
Recruitment arrangements (for publication)	K3_Recruitment materials_Reference Guide	1
Recruitment arrangements (for publication)	K4_Patient card	1
Recruitment arrangements (for publication)	K4_Recruitment material Poster	1
Recruitment arrangements (for publication)	K5_Recruitment material Flyer	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF IAF	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF Main REDACTED	3
Subject information and informed consent form (for publication)	L1_ SIS and ICF Optional PET Scan REDACTED	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF RBR	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF Study partner REDACTED	2
Subject information and informed consent form (for publication)	L1_Appendix 1 GDPR	1
Subject information and informed consent form (for publication)	L1_ICF Caregiver_redacted	1
Subject information and informed consent form (for publication)	L1_ICF Main_redacted	1
Subject information and informed consent form (for publication)	L1_ICF Optional Tau PET_redacted	1
Subject information and informed consent form (for publication)	L1_other subject information material_APOE Result Explainer Booklet_DE_WN45443	1
Subject information and informed consent form (for publication)	L1_Privacy consent form other subjects	1.0
Subject information and informed consent form (for publication)	L1_Recruitment Arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF IAF	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF IAF	1
Subject information and informed consent form (for publication)	L1_SIS and ICF MAIN_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF MAIN_WN45443_redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Participant_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Partner_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF PET Tau_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregnant Patient_WN45443	1
Subject information and informed consent form (for publication)	L1_SIS and ICF RBR	1
Subject information and informed consent form (for publication)	L1_SIS and ICF STUDY PARTNER_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF TAU-PET_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Caregiver_WN45443_redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_IAF	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional PET Tau_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_RBR	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_RBR_WN45443	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Study Partner_Redacted	2
Subject information and informed consent form (for publication)	L2_APOE Result Explainer Booklet	1
Subject information and informed consent form (for publication)	L2_APOE Result Explainer Booklet_CAT	1
Subject information and informed consent form (for publication)	L2_APOE Result Explainer Booklet_ES	1
Subject information and informed consent form (for publication)	L2_Other subject information material APOE Explainer	1
Subject information and informed consent form (for publication)	L2_Other subject information material APOE result explainer booklet	1
Subject information and informed consent form (for publication)	L2_Other subject information material_APOE Result Explainer Booklet	1
Subject information and informed consent form (for publication)	L2_Right to not know	1
Subject information and informed consent form (for publication)	L2_Your rights as a Trial Participant	1
Synopsis of the protocol (for publication)	d1_protocol-synopsis_de_de-2024-518006-40-00	3
Synopsis of the protocol (for publication)	d1_protocol-synopsis_en_gb-2024-518006-40-00	3
Synopsis of the protocol (for publication)	d1_protocol-synopsis_es_es-2024-518006-40-00	3
Synopsis of the protocol (for publication)	d1_protocol-synopsis_fr_fr-2024-518006-40-00	3
Synopsis of the protocol (for publication)	d1_protocol-synopsis_it-it-2024-518006-40-00	3
Synopsis of the protocol (for publication)	d1_protocol-synopsis_pl_pl-2024-518006-40-00	3

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-07-15	Denmark	Acceptable with conditions 2025-11-03	2025-11-04
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-11	Denmark	Acceptable with conditions 2025-11-03	2025-11-11
3	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-11-12		Acceptable with conditions 2025-11-03	2025-11-12
4	NON SUBSTANTIAL MODIFICATION	NSM-3	2025-11-18		Acceptable with conditions 2025-11-03	2025-11-18
5	SUBSTANTIAL MODIFICATION	SM-1	2025-11-19		Acceptable with conditions	2025-12-15
6	SUBSTANTIAL MODIFICATION	SM-2	2025-11-20		Acceptable with conditions	2025-12-05
7	NON SUBSTANTIAL MODIFICATION	NSM-5	2026-02-05	Denmark	Acceptable with conditions	2026-02-05

An Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

Overview

Key facts

Trial design

Main objective

Secondary objectives 4

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 6

Endpoints

Primary endpoints 1

Secondary endpoints 14

Investigational products

Test 1

Placebo 1

Auxiliary 7

Sponsors and contacts

F. Hoffmann-La Roche AG

Scientific contact point

Public contact point

Third parties 10

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 81 files

Application history

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