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A 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)

Status: Recruiting
Location: See all (146) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Banner Alzheimer?s Institute
RECRUITING
Phoenix
California
Sun Valley Research Center, Inc.
RECRUITING
Imperial
Healthy Brain Clinic
RECRUITING
Long Beach
Oakland Clinical
RECRUITING
Oakland
Riverside Clinical
RECRUITING
Riverside
Cenexel California Neuroscience Research, LLC
RECRUITING
Sherman Oaks
Connecticut
Yale University
RECRUITING
New Haven
Florida
JEM Research LLC
RECRUITING
Atlantis
K2 Medical Research-Winter Garden
RECRUITING
Clermont
Visionary Investigators Network- Neurology Aventura
RECRUITING
Miami
Charter Research - Winter Park/Orlando
RECRUITING
Orlando
Conquest Research - Lake Nona
RECRUITING
Orlando
Alzheimer's Research and Treatment Center
RECRUITING
Stuart
Georgia
CenExel iResearch, LLC
RECRUITING
Decatur
Center for Advanced Research & Education
RECRUITING
Gainesville
Illinois
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
RECRUITING
Chicago
Massachusetts
Adams Clinical Boston
RECRUITING
Boston
Adams Clinical Watertown
RECRUITING
Watertown
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
The Cognitive and Research Center of New Jersey
RECRUITING
Springfield
New York
AD-CARE, University of Rochester Medical Center
RECRUITING
Rochester
Oregon
Summit Research Network Inc.
RECRUITING
Portland
Pennsylvania
Flourish Research ? Philadelphia
RECRUITING
Plymouth Meeting
Texas
Gadolin Research, LLC
RECRUITING
Beaumont
Kerwin Medical Center
RECRUITING
Dallas
Re:Cognition Health - Fort Worth
RECRUITING
Fort Worth
Mt.Olympus Medical Research
RECRUITING
Katy
El Faro Health and Therapeutics
RECRUITING
Rio Grande City
Virginia
Sana Research, LLC
RECRUITING
Arlington
Re:Cognition Health
RECRUITING
Fairfax
Other Locations
Argentina
Fundacion Scherbovsky
RECRUITING
Mendoza
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Box Hill Hospital
RECRUITING
Box Hill
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Austin Health
RECRUITING
Heidelberg
Southern Neurology
RECRUITING
Kogarah
KaRa Institute of Neurological Diseases
RECRUITING
Macquarie Park
Alfred Hospital
RECRUITING
Melbourne
Alzheimer?s Research Australia
RECRUITING
Nedlands
Queen Elizabeth Hospital
RECRUITING
Woodville
Brazil
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
RECRUITING
Brasília
Instituto de Neurologia de Curitiba
RECRUITING
Curitiba
Clinica Neurologica
RECRUITING
Joinville
Clinica Clinilive ltda
RECRUITING
Maringá
Instituto do Cerebro do Rio Grande do Sul
RECRUITING
Porto Alegre
CEMEC - Centro Multidisciplinar de Estudos Clínicos
RECRUITING
São Bernardo Do Campo
Canada
Centricity Research
RECRUITING
Halifax
Okanagan Clinical Trials
RECRUITING
Kelowna
Parkwood Institute Main Building
RECRUITING
London
Genge Partners Inc.
RECRUITING
Montreal
The Ottawa Memory Clinic
RECRUITING
Ottawa
Kawartha Centre - Redefining Healthy Aging
RECRUITING
Peterborough
St. Michael's Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Denmark
Aalborg Universitetshospital
RECRUITING
Aalborg
Aarhus Universitetshospital Skejby
RECRUITING
Aarhus N
Rigshospitalet, Hukommelsesklinikken
RECRUITING
København Ø
France
CHU Amiens Hopital Sud
RECRUITING
Amiens Cedex1
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
RECRUITING
Bordeaux
Groupement Hospitalier Est - Hôpital Neurologique
RECRUITING
Bron
CHU Dupruytren - Limoges
RECRUITING
Limoges
Hopital Gui de Chauliac
RECRUITING
Montpellier
Ch Pitie Salpetriere
RECRUITING
Paris
CHU de Rouen Hopital
RECRUITING
Rouen
Hop Guillaume Et Rene Laennec
RECRUITING
Saint-herblain
Hôpital Robertsau
RECRUITING
Strasbourg
Germany
Ambulates Gesundheitszentrum der Charité GmbH
RECRUITING
Berlin
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
RECRUITING
Berlin
German Center for Neurodegenerative Diseases (DZNE)
RECRUITING
Bonn
Universitätsklinikum Köln
RECRUITING
Cologne
Medizinische Fakultät Carl Gustav Carus
RECRUITING
Dresden
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
RECRUITING
Homburg/saar
Universitätsklinikum Jena, Klinik für Neurologie
RECRUITING
Jena
Universität Leipzig
RECRUITING
Leipzig
Otto-von-Guericke-Universität Magdeburg
RECRUITING
Magdeburg
Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
RECRUITING
Mannheim
LMU Klinikum, Neurologische Klinik und Poliklinik
RECRUITING
München
Ludwig-Maximilians-Univ.
RECRUITING
München
Universitätsklinikum Münster
RECRUITING
Münster
Neuropraxis München Süd
RECRUITING
Unterhaching
Italy
Nuovo Ospedale Civile S. Agostino-Estense
RECRUITING
Modena
A. O. U. Federico II
RECRUITING
Naples
AO di Perugia - Ospedale S. Maria della Misericordia
RECRUITING
Perugia
Ospedale Isola Tiberina - Gemelli Isola
RECRUITING
Rome
Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Japan
Brain Attack Center Ota Memorial Hospital
RECRUITING
Hiroshima
National Hospital Organization Hiroshima-Nishi Medical Center
RECRUITING
Hiroshima
Kobe University Hospital
RECRUITING
Hyōgo
Kagawa University Hospital
RECRUITING
Kagawa
Kochi Medical School Hospital
RECRUITING
Kochi
Okayama City Hospital
RECRUITING
Okayama
Rijikai Medical Corporation Katayama Medical Clinic
RECRUITING
Okayama
Kotobuki Social Medical Corporation Tominaga Clinic
RECRUITING
Osaka
Higashi-Shinjuku Clinic
RECRUITING
Tokyo
The University of Tokyo Hospital
RECRUITING
Tokyo
Netherlands
Brain Research Center Den Bosch
RECRUITING
's-hertogenbosch
Brain Research Center B.V
RECRUITING
Amsterdam
Brain Research Center Zwolle
RECRUITING
Zwolle
Poland
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
RECRUITING
?cinawa
Uniwersytet Medyczny w Lodzi
RECRUITING
?ód?
ProNeuro Centrum Medyczne
RECRUITING
?ory
Syberka-ClinHouse Sp. z o.o.
RECRUITING
B?dzin
Podlaskie Centrum Psychogeriatrii
RECRUITING
Bia?ystok
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
RECRUITING
Późna
Centrum Medyczne MEDYK
RECRUITING
Rzeszów
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
RECRUITING
Sopot
NeuroProtect
RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Chonnam National University Hospital
RECRUITING
Gwangju
Ajou University Medical Center
RECRUITING
Gyeonggi-do
St. Vincent's Hospital
RECRUITING
Gyeonggi-do
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Ewha Womans University Hospital (Seoul)
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Spain
Fundación ACE
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Victoria Eugenia
RECRUITING
Seville
Hospital Virgen del Rocío
RECRUITING
Seville
Hospital Universitario la Fe
RECRUITING
Valencia
Switzerland
Inselspital Bern Medizin Neurologie
RECRUITING
Bern
Hôpitaux universitaires de Genève
RECRUITING
Geneva
CHUV Lausanne Méd.Neurologie
RECRUITING
Lausanne
Ospedale Regionale di Lugano - Civico
RECRUITING
Lugano
United Kingdom
ReMind UK
RECRUITING
Bath
Re:Cognition Health Birmingham
RECRUITING
Birmingham
Scottish Brain Sciences
RECRUITING
Edinburgh
Queen Elizabeth University Hospital Glasgow
RECRUITING
Glasgow
RE:Cognition Health
RECRUITING
London
St George?s Hospital
RECRUITING
London
UCL Institute of Neurology
RECRUITING
London
Manchester Mental Health and Social Care Trust
RECRUITING
Manchester
Warneford Hospital
RECRUITING
Oxford
Lancashire and South Cumbria NHS Foundation Trust
RECRUITING
Preston
Southampton University Hospitals NHS Trust
RECRUITING
Southampton
Contact Information
Primary
Reference Study ID Number: WN45447 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2028-06-07
Participants
Target number of participants: 800
Treatments
Experimental: Trontinemab
Participants will receive intravenous (IV) trontinemab.
Placebo_comparator: Placebo
Participants will receive IV placebo.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov