A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Hoffmann-La Roche
Sponsor
Hoffmann-La Roche
Information Provided by (Responsible Party)
Hoffmann-La Roche
Clinicaltrials.gov Identifier
NCT07170150
Other Study ID Numbers:
WN45447
First Submitted
September 9, 2025
First Posted
September 11, 2025
Last Update Posted
May 10, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Alzheimers Disease
Drug: TrontinemabOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment800 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)
Study Start DateNovember 11, 2025
Actual Primary Completion Date2yrs 3w from now
Actual Study Completion Date2yrs 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Trontinemab
Participants will receive intravenous (IV) trontinemab.
Drug: Trontinemab
Participants will receive IV trontinemab
Placebo
Participants will receive IV placebo.
Other: Placebo
Participants will receive IV placebo

Outcome Measures

Primary Outcome Measures
  1. Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Secondary Outcome Measures
  1. Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
  2. Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score
  3. Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
  4. Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)
  5. Change from baseline in CDR-SB
  6. Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)
  7. Percentage of participants with adverse events (AEs)
  8. Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings
  9. Percentage of participants with infusion-related reactions (IRR)
  10. Percentage of participants with anti-drug antibodies (ADAs) to trontinemab
  11. Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan
  12. Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants
  13. Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants
  14. Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
Availability of a "study partner" as defined by the protocol
Exclusion Criteria
Any evidence of a condition other than AD that may affect cognition
History or presence of clinically significant cerebrovascular disease
History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
History or presence of clinically significant intracranial mass
MRI evidence of significant cerebral abnormalities or 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 of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Contacts and Locations

Sponsors and CollaboratorsHoffmann-La Roche
Locations
Banner Alzheimer?s Institute | Phoenix Arizona, United States, 85006Sun Valley Research Center, Inc. | Imperial California, United States, 92251Healthy Brain Clinic | Long Beach California, United States, 90804Oakland Clinical | Oakland California, United States, 94609Riverside Clinical | Riverside California, United States, 92506Cenexel California Neuroscience Research, LLC | Sherman Oaks California, United States, 91403Yale University | New Haven Connecticut, United States, 06510JEM Research LLC | Atlantis Florida, United States, 33462K2 Medical Research-Winter Garden | Clermont Florida, United States, 34711Visionary Investigators Network- Neurology Aventura | Miami Florida, United States, 33133Charter Research - Winter Park/Orlando | Orlando Florida, United States, 32803Conquest Research - Lake Nona | Orlando Florida, United States, 32832Alzheimer's Research and Treatment Center | Stuart Florida, United States, 34997CenExel iResearch, LLC | Decatur Georgia, United States, 30030Center for Advanced Research & Education | Gainesville Georgia, United States, 30501Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville | Chicago Illinois, United States, 60640Adams Clinical Boston | Boston Massachusetts, United States, 02116Adams Clinical Watertown | Watertown Massachusetts, United States, 02472Quest Research Institute | Farmington Hills Michigan, United States, 48334University of Nebraska Medical Center | Omaha Nebraska, United States, 68198-8440The Cognitive and Research Center of New Jersey | Springfield New Jersey, United States, 07081IMA Clinical Research - Albuquerque | Albuquerque New Mexico, United States, 87109AD-CARE, University of Rochester Medical Center | Rochester New York, United States, 14620Summit Research Network Inc. | Portland Oregon, United States, 97210Flourish Research ? Philadelphia | Plymouth Meeting Pennsylvania, United States, 19462Palmetto Clinical Trials | Summerville South Carolina, United States, 29485Gadolin Research, LLC | Beaumont Texas, United States, 77702Kerwin Medical Center | Dallas Texas, United States, 75216Re:Cognition Health - Fort Worth | Fort Worth Texas, United States, 76104Mt.Olympus Medical Research | Katy Texas, United States, 77450El Faro Health and Therapeutics | Rio Grande City Texas, United States, 78582Sana Research, LLC | Arlington Virginia, United States, 22205Re:Cognition Health | Fairfax Virginia, United States, 22031INECO Neurociencias Orono | Rosario Santa Fe Province, Argentina, S2000DTCCIER | C. A. B. A. , Argentina, C1055AAFFundacion Scherbovsky | Mendoza , Argentina, 5500Royal Prince Alfred Hospital | Camperdown New South Wales, Australia, 2050Southern Neurology | Kogarah New South Wales, Australia, 2217KaRa Institute of Neurological Diseases | Macquarie Park New South Wales, Australia, 2113Flinders Medical Centre | Bedford Park South Australia, Australia, 5042Queen Elizabeth Hospital | Woodville South Australia, Australia, 5011Box Hill Hospital | Box Hill Victoria, Australia, 3128Austin Health | Heidelberg Victoria, Australia, 3084Alfred Hospital | Melbourne Victoria, Australia, 3004Alzheimer?s Research Australia | Nedlands Western Australia, Australia, 6009L2 Ip Instituto de Pesquisas Clinicas Ltda ME | Brasília Federal District, Brazil, 70200-730Instituto de Neurologia de Curitiba | Curitiba Paraná, Brazil, 81210-310Clinica Clinilive ltda | Maringá Paraná, Brazil, 87013-250Instituto do Cerebro do Rio Grande do Sul | Porto Alegre Rio Grande do Sul, Brazil, 90610-000Clinica Neurologica | Joinville Santa Catarina, Brazil, 89202-190CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo São Paulo, Brazil, 09715-090Okanagan Clinical Trials | Kelowna British Columbia, Canada, V1Y 1Z9Centricity Research | Halifax Nova Scotia, Canada, B3S 1N2Parkwood Institute Main Building | London Ontario, Canada, N6C0A7The Ottawa Memory Clinic | Ottawa Ontario, Canada, K1Z 1G3Kawartha Centre - Redefining Healthy Aging | Peterborough Ontario, Canada, K9H 2P4Sunnybrook Health Sciences Centre | Toronto Ontario, Canada, M4N 3M5St. Michael's Hospital | Toronto Ontario, Canada, M5B 1W8Genge Partners Inc. | Montreal Quebec, Canada, H4A 3T2Aalborg Universitetshospital | Aalborg , Denmark, 9000Aarhus Universitetshospital Skejby | Aarhus N , Denmark, 8200Rigshospitalet, Hukommelsesklinikken | København Ø , Denmark, 2100CHU Amiens Hopital Sud | Amiens Cedex1 , France, 80054Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin | Bordeaux , France, 33076Groupement Hospitalier Est - Hôpital Neurologique | Bron , France, 69677CHU Dupruytren - Limoges | Limoges , France, 87042Hopital Gui de Chauliac | Montpellier , France, 34295Ch Pitie Salpetriere | Paris , France, 75651CHU de Rouen Hopital | Rouen , France, 76031Hop Guillaume Et Rene Laennec | Saint-Herblain , France, 44800Hôpital Robertsau | Strasbourg , France, 67000Universitaetsklinikum Erlangen | Erlangen Bavaria, Germany, 91054Ambulates Gesundheitszentrum der Charité GmbH | Berlin , Germany, 12200ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic | Berlin , Germany, 13125German Center for Neurodegenerative Diseases (DZNE) | Bonn , Germany, 53127Universitätsklinikum Köln | Cologne , Germany, 50937Medizinische Fakultät Carl Gustav Carus | Dresden , Germany, 01307Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie | Homburg/Saar , Germany, 66421Universitätsklinikum Jena, Klinik für Neurologie | Jena , Germany, 07747Universität Leipzig | Leipzig , Germany, 04103Otto-von-Guericke-Universität Magdeburg | Magdeburg , Germany, 39120Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie | Mannheim , Germany, 68159LMU Klinikum, Neurologische Klinik und Poliklinik | München , Germany, 81377Ludwig-Maximilians-Univ. | München , Germany, 81377Universitätsklinikum Münster | Münster , Germany, 48149Neuropraxis München Süd | Unterhaching , Germany, 82008A. O. U. Federico II | Naples Campania, Italy, 80131Nuovo Ospedale Civile S. Agostino-Estense | Modena Emilia-Romagna, Italy, 41126Policlinico Universitario Agostino Gemelli | Rome Lazio, Italy, 00168Ospedale Isola Tiberina - Gemelli Isola | Rome Lazio, Italy, 00186AO di Perugia - Ospedale S. Maria della Misericordia | Perugia Umbria, Italy, 06156Brain Attack Center Ota Memorial Hospital | Hiroshima , Japan, 720-0825National Hospital Organization Hiroshima-Nishi Medical Center | Hiroshima , Japan, 739-0696Kobe University Hospital | Hyōgo , Japan, 650-0017Kagawa University Hospital | Kagawa , Japan, 761-0793Kochi Medical School Hospital | Kochi , Japan, 783-8505Okayama City Hospital | Okayama , Japan, 700-8557Rijikai Medical Corporation Katayama Medical Clinic | Okayama , Japan, 710-0813Kotobuki Social Medical Corporation Tominaga Clinic | Osaka , Japan, 556-0015The University of Tokyo Hospital | Tokyo , Japan, 113-8655Higashi-Shinjuku Clinic | Tokyo , Japan, 169-0072Brain Research Center Den Bosch | 's-Hertogenbosch , Netherlands, 5223 LABrain Research Center B.V | Amsterdam , Netherlands, 1081 GNBrain Research Center Zwolle | Zwolle , Netherlands, 8025AZO?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie | ?cinawa , Poland, 59-330ProNeuro Centrum Medyczne | ?ory , Poland, 44-240Uniwersytet Medyczny w Lodzi | ?ód? , Poland, 92-216Syberka-ClinHouse Sp. z o.o. | B?dzin , Poland, 42-500Podlaskie Centrum Psychogeriatrii | Bia?ystok , Poland, 15-756Uniwersyteckie Centrum Kliniczne | Gdansk , Poland, 80-214Szpital Uniwersytecki w Krakowie | Krakow , Poland, 30-688Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa | Późna , Poland, 61-731Centrum Medyczne "MEDYK" | Rzeszów , Poland, 35-326Senior Sp. Z O.O. Poradnia Psychogeriatryczna | Sopot , Poland, 81-855NeuroProtect | Warsaw , Poland, 01-684Pusan National University Hospital | Busan , South Korea, 602-739Chonnam National University Hospital | Gwangju , South Korea, 61469Ajou University Medical Center | Gyeonggi-do , South Korea, 16499St. Vincent's Hospital | Gyeonggi-do , South Korea, 442-723Gachon University Gil Medical Center | Incheon , South Korea, 21565Inha University Hospital | Incheon , South Korea, 22332Seoul National University Bundang Hospital | Seongnam-si , South Korea, 463-707Hanyang University Seoul Hospital | Seoul , South Korea, 04763Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351Ewha Womans University Hospital (Seoul) | Seoul , South Korea, 07804Korea University Guro Hospital | Seoul , South Korea, 08308Hospital Universitario Marques de Valdecilla | Santander Cantabria, Spain, 39011Fundación ACE | Barcelona , Spain, 08028Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08041Hospital Ramon y Cajal | Madrid , Spain, 28034Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Victoria Eugenia | Seville , Spain, 41009Hospital Virgen del Rocío | Seville , Spain, 41013Hospital Universitario la Fe | Valencia , Spain, 46026Inselspital Bern Medizin Neurologie | Bern , Switzerland, 3010Hôpitaux universitaires de Genève | Geneva , Switzerland, 1211CHUV Lausanne Méd.Neurologie | Lausanne , Switzerland, 1011Ospedale Regionale di Lugano - Civico | Lugano , Switzerland, 6903ReMind UK | Bath , United Kingdom, BA1 3NGRe:Cognition Health Birmingham | Birmingham , United Kingdom, B16 8QQScottish Brain Sciences | Edinburgh , United Kingdom, EH12 9DQQueen Elizabeth University Hospital Glasgow | Glasgow , United Kingdom, G51 4TFSt George?s Hospital | London , United Kingdom, SW17 ORERE:Cognition Health | London , United Kingdom, W1G 8TAUCL Institute of Neurology | London , United Kingdom, WC1N 3BGManchester Mental Health and Social Care Trust | Manchester , United Kingdom, M13 9WLWarneford Hospital | Oxford , United Kingdom, OX3 7JXLancashire and South Cumbria NHS Foundation Trust | Preston , United Kingdom, PR2 8DWSouthampton University Hospitals NHS Trust | Southampton , United Kingdom, SO16 6YD
Investigators
Study Director: Clinical Trials, Hoffmann-La Roche