Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
800
Countries
7
Sites
91
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
- 12 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: Efficacy, Pharmacodynamic, Safety, Others
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
- NA
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 events (AEs) and serious adverse events (SAEs)
- 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)
- 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
- Nature, frequency, severity, and timing of infusion-related reactions (IRRs)
- Incidence and titer of anti-drug antibodies (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 amyloid 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
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
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 8
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
VIZAMYL 400 MBq/mL solution for injection
PRD10888610 · 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/1/14/941/002
- MA holder
- GE HEALTHCARE AS
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different manufacturing
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
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 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
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 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
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 |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
| Woodley Equipment Company Limited ORG-100043990
|
Bolton, 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 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 91 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 12 | 3 |
| France | Ongoing, recruiting | 35 | 17 |
| Germany | Ongoing, recruiting | 40 | 30 |
| Italy | Ongoing, recruiting | 45 | 12 |
| Netherlands | Ongoing, recruiting | 20 | 4 |
| Poland | Ongoing, recruiting | 55 | 16 |
| Spain | Ongoing, recruiting | 40 | 9 |
| Rest of world
United States, Korea, Republic of, United Kingdom, Brazil, Argentina, Australia, Canada, Switzerland, Japan
|
— | 553 | — |
Investigational sites
Aalborg University Hospital
Neurologisk Afdeling, Demensenheden, Ladegaardsgade 5, 9000, Aalborg
Rigshospitalet
Hukommelsesklinikken, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Region Midtjylland
Neurologisk forskning, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Et Universitaire De Limoges
Hôpital Dupuytren, 2 Avenue Martin Luther King, 87000, Limoges
Hospices Civils De Lyon
Hôpital des Charpennes, 27 Rue Gabriel Peri, 69100, Villeurbanne
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 Regional De Marseille
Hôpital de la Timone, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire Amiens Picardie
CHU Amiens, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Rennes
Hôpital Pontchaillou, 2 Rue Henri Le Guilloux, 35000, Rennes
Hospices Civils De Lyon
Hôpital neurologique Pierre Wertheimer, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Hôpital La pitié Salpêtrière, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire De Bordeaux
Hôpital Pellegrin, Place Amelie Raba Leon, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Hôpital Lariboisière Fernand-Widal, 2 Rue Ambroise Pare, 75010, Paris
Centre Hospitalier Universitaire De Montpellier
Hôpital Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Toulouse
Hôpital la Grave, 9 Place Lange, 31300, Toulouse
Centre Hospitalier Universitaire De Nantes
Hôpital Laennec, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Regional Universitaire De Tours
Hôpital Bretonneau, 2 Boulevard Tonnelle, 37000, Tours
Les Hopitaux Universitaires De Strasbourg
Hôpital de la Robertsau, 21 Rue David Richard, 67000, Strasbourg
Centre Hospitalier Universitaire Rouen
Hôpital Charles Nicolle, 1 Rue De Germont, Bp 96031, Rouen Cedex
LMU Klinikum Muenchen AöR
Klinik für Psychiatrie und Psychotherapie, Nussbaumstrasse 7, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Magdeburg AöR
Universitätsklinik für Neurologie, Leipziger Strasse 44, 39120, Magdeburg
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma-Forschungszentrum (HRF), Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Klinikum Bayreuth GmbH
Klinik für Neurologie; Klinik Hohe Warte Bayreuth, Hohe Warte 8, Gruener Baum, Bayreuth
Universitaetsklinikum Ulm AöR
Klinik für Neurologie/Gedächtnisambulanz, Oberer Eselsberg 45, Eselsberg, Ulm
Neuropraxis München Süd
Praxis, Hauptstraße 2, 82008, Unterhaching
University Hospital Cologne AöR
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Kerpener Strasse 62, Lindenthal, Cologne
LMU Klinikum Muenchen AöR
Institut für Schlaganfall- und Demenzforschung (ISD), Feodor-Lynen-Strasse 17, Hadern, Munich
Charite Universitaetsmedizin Berlin KöR
Campus Benjamin Franklin, Hindenburgdamm 30, Lichterfelde, Berlin
LMU Klinikum Muenchen AöR
Neurologische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Gesundheit Nord gGmbH Klinikverbund Bremen
Klinikum Bremen-Ost, Zuericher Strasse 40, Ellenerbrok-Schevemoor, Bremen
Universitaetsmedizin Goettingen
Klinik für Psychiatrie und Psychotherapie, Von-Siebold-Strasse 5, 37075, Goettingen
Charite Universitaetsmedizin Berlin KöR
Experimental and Clinical Research Center (ECRC), Lindenberger Weg 80, Buch, Berlin
St. Josef-Hospital
Klinik für Neurologie, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Aachen AöR
Klinik für Neurologie, Pauwelsstrasse 30, 52074, Aachen
Universitaet Leipzig
Klinik und Poliklinik für Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Neuro Centrum Science GmbH
Praxis, Albert-Schweitzer-Strasse 8, 64711, Erbach
Medical Center - University Of Freiburg
Klinik für Neurologie und Neurophysiologie, Breisacher Strasse 64, Stuehlinger, Freiburg Im Breisgau
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Praxis, Hessenring 121, 61348, Bad Homburg
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Klinik für Alterspsychiatrie und Kognitive Störungen, Venusberg-Campus 1/99, Venusberg, Bonn
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Neurologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Barmherzige Brueder Trier gGmbH
Abteilung für Neurologie, Nordallee 1, Trier-Nord, Trier
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik für Psychiatrie und Psychotherapie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Zentralinstitut Fuer Seelische Gesundheit
ZI, Luisenring J 5, 68159, Mannheim
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
Neurologie Berlin, Schloßstraße 29, 12163, Berlin
Universitaet Des Saarlandes
Klinik für Psychiatrie und Psychotherapie, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Jena KöR
Klinik für Neurologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Erlangen AöR
Psychiatrische und Psychotherapeutische Klinik, Schwabachanlage 6, Innenstadt, Erlangen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
Klinik für Neurologie mit Institut für Translationale Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Fondazione IRCCS San Gerardo Dei Tintori
S.C. Neurology, Via Giovanni Battista Pergolesi 33, 20900, Monza
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
Fondazione Santa Lucia
Neurologia e Riabilitazione Neurologica, Via Ardeatina 306, 00179, 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
Hospital Santa Maria Della Misericordia
Section of Neurology Dept. of Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Neurologia, Largo Francesco Vito 1, 00168, Rome
Pia Fondazione Di Culto E Religione Card G Panico
UOC Malattie Neurodegenerative, Via Pio X 4, 73039, Tricase
Ospedale Isola Tiberina Gemelli Isola
Neurologia, Via Di Ponte Quattro Capi 39, 00186, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dept. of Human Neurosciences - DAI Neuroscienze/Salute Mentale, Viale Del Policlinico 155, 00161, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Departement of Biomedical, Metabolic and Neural Sciences, Largo Francesco Vito 1, 00168, Rome
Brain Research Center Amsterdam B.V.
NA, Cronenburg 2, 1081 GN, Amsterdam
Brain Research Center Den Bosch B.V.
NA, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Amphia Hospital
Neurology, Molengracht 21, 4818 CK, Breda
Brain Research Center Zwolle B.V.
NA, Dokter Stolteweg 90, 8025 AZ, Zwolle
NZOZ Wrocławskie Centrum Alzheimerowskie
NA, Al. Gen. Władysława Sikorskiego 7/GHJ, 53-659, Wrocław
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Klinika Psychiatrii Wieku Podeszłego i Zaburzeń Psychotycznych, Ul. Czechoslowacka 8/10, 92-216, Lodz
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Neurologii, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Clinical Research Center Sp. z o.o. Medic-R sp.k.
NA, Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Centrum Medyczne Neuromed Sp. z o.o.
NA, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Etg Neuroscience Sp. z o.o.
NA, Ul. Wynalazek 4, 02-677, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Syberka-Clinhouse Sp. z o.o.
NA, Ul. Zwyciestwa 30, 42-500, Bedzin
Centrum Medyczne Neuroprotect
NA, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych Im. Ksiedza Henryka Kardynala Gulbinowicza Osrodek Alzheimerowski Sp. z o.o.
NA, Ul. Jana Pawla II Nr 12, 59-330, Scinawa
Uniwersyteckie Centrum Kliniczne
Klinika Neurologii Dorosłych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Podlaskie Centrum Psychogeriatrii
NA, ul. Swobodna 38, 15-756, Białystok
Centrum Medyczne Medyk Sp. z o.o. S.K.
NA, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Centrum Medyczne Senior
Poradnia Psychogeriatryczna, Ul. Rzemieslnicza 3, 81-855, Sopot
ProNeuro Centrum Medyczne
NA, ul. Aleja Zjednoczonej Europy 37, 44-240, Zory
Neuro-Care Sp. z o.o. sp.k.
NA, Ul. Pawla Kolodzieja 8, 40-749, Katowice
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital San Pedro
Neurology, Calle Piqueras 98, 26006, Logrono
Hospital Universitario Marques De Valdecilla
Neurology, Avenida Valdecilla Sn, 39008, Santander
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Victoria Eugenia De La Cruz Roja Espanola
Neurology, Avenida La Cruz Roja 1, 41009, Sevilla
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Fundacio Ace Institut Catala De Neurociencies Aplicades
Neurology, Gran Via De Carles III 85 Bis, 08028, Barcelona
Hospital Universitario 12 De Octubre
Neurology, Avenida De Cordoba Sn, 28041, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-12-01 | 2026-01-06 | |||
| France | 2025-11-12 | 2025-11-13 | |||
| Germany | 2025-11-18 | 2025-11-18 | |||
| Italy | 2026-01-08 | 2026-01-12 | |||
| Netherlands | 2026-01-23 | 2026-01-27 | |||
| Poland | 2025-11-19 | 2025-11-24 | |||
| Spain | 2025-11-17 | 2025-11-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 94 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2024-518008-33-00-redacted | 1 EEA only |
| Protocol (for publication) | d4_patient-facing-documents_memo | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1.1 |
| 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 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_WN45447 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Link2Trials social media BRC sites_REDACTED | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Presentation BRC sites_REDACTED | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Study Web Posting BRC sites_EN_REDACTED | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Study Web Posting BRC sites_NL_REDACTED | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Inclusive Research Guide | 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 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_Trontier 1_Online banner V1_DE_WN45447 | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trontier 2_Flyer_DE_WN45447 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trontier 2_Inclusive Research Guide_DE_WN45447 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trontier 2_Poster_DE_WN45447 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Placeholder | 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_Recrutiment material_Social media support_CAT | 1 |
| Recruitment arrangements (for publication) | K2_Recrutiment material_Social media support_ES | 1 |
| Recruitment arrangements (for publication) | K2_Roche_Alzheimer_RollUp QR_Code 1_WN45447 | 1 |
| Recruitment arrangements (for publication) | K2_Roche_Alzheimer_RollUp QR_Code 2_WN45447_ | 1 |
| Recruitment arrangements (for publication) | K2_WN45447_Recruitment materials_Placeholder | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment materials_Placeholder | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment materials_Reference Guide | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment materials_Social Media posts | 1 |
| Recruitment arrangements (for publication) | K4_Patient card | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment materials_Poster | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment materials_Flyer | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Caregiver_REDACTED | 1.1 |
| 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 Infant Authorization | 1.0 |
| 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_REDACTED | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional TAU Scan_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RBR | 1.0 |
| 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 Tau PET scan_REDACTED | 1.0 |
| 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_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 |
| 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 MAIN_REDACTED | 1.1 |
| 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 MAIN_WN45447_redacted | 5 |
| 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 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 RBR | 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 RBR_WN45447 | 3.0 |
| 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 Study Partner_REDACTED | 2 |
| 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_WN45447_redacted | 4 |
| 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_PregnantPatient_WN45447 | 1 |
| 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 | 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_other subject information material_APOE Result Explainer Booklet_DE_WN45447 | 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_en_gb-2024-518008-33-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es_es-2024-518008-33-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr_fr-2024-518008-33-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2024-518008-33-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_nl_nl-2024-518008-33-00 | 3 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl_pl-2024-518008-33-00 | 1 |
Application history
5 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 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-20 | Acceptable with conditions | 2026-01-16 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-06 | Denmark | Acceptable with conditions | 2026-02-06 |