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 (69) locations...
Intervention Type: Other, Drug
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
California
Inglewood Clinicals
RECRUITING
Inglewood
Irvine Center for Clinical Research
RECRUITING
Irvine
Syrentis Clinical Research
RECRUITING
Santa Ana
Florida
K2 Medical Research - The Villages
RECRUITING
Lady Lake
K2 Medical Research, LLC
RECRUITING
Maitland
Renstar Medical Research
RECRUITING
Ocala
Axiom Brain Health LLC
RECRUITING
Tampa
Charter Research - Lady Lake/The Villages
RECRUITING
The Villages
Alzheimer?s Research and Treatment Center
RECRUITING
Wellington
Conquest Research, LLC
RECRUITING
Winter Park
Georgia
Accel Research Sites-NeuroStudies
RECRUITING
Decatur
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Massachusetts
Boston Center for Memory
RECRUITING
Newton
North Carolina
Triad Clinical Trials
RECRUITING
Greensboro
New Jersey
The Cognitive and Research Center of New Jersey
RECRUITING
Ridgewood
New York
Basil Clinical
RECRUITING
Laurelton
Adams Clinical Harlem
RECRUITING
New York
Texas
Kerwin Research Center, LLC
RECRUITING
Dallas
Virginia
National Clinical Research Inc.-Richmond
RECRUITING
Richmond
Other Locations
Canada
Alpha Recherche Clinique
RECRUITING
Québec
Richmond Clinical Trials
RECRUITING
Richmond
Toronto Memory Program
RECRUITING
Toronto
China
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital, Chongqing Medical University
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Nanjing First Hospital
RECRUITING
Nanjing
Zhongda Hospital Affiliated to Southeast University
RECRUITING
Nanjing
Huashan Hospital, Fudan University
RECRUITING
Shanghai
France
Hopital B Roger Salengro
RECRUITING
Lille
Hôpital de la Timone
RECRUITING
Marseille
Hopital Lariboisiere
RECRUITING
Paris
CHU Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Gerontopole
RECRUITING
Toulouse
Hopital des Charpennes
RECRUITING
Villeurbanne
Germany
Uniklinik RWTH Aachen
RECRUITING
Aachen
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
RECRUITING
Freiburg Im Breisgau
MVZ Rheumatologie und Autoimummedizin Hamburg GmbH
RECRUITING
Hamburg
Klinikum rechts der Isar der TU München
RECRUITING
München
Universitätsklinikum Ulm
RECRUITING
Ulm
Japan
National Hospital Organization Utano National Hospital
RECRUITING
Kyoto
Mishuku Hospital
RECRUITING
Meguro-ku
Mie University Hospital
RECRUITING
Mie
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
RECRUITING
Tokyo
Memory Clinic Ochanomizu
RECRUITING
Tokyo
National Center of Neurology and Psychiatry
RECRUITING
Tokyo
P-One Clinic
RECRUITING
Tokyo
Yamagata Tokusyukai Hospital
RECRUITING
Yamagata
Poland
Centrum Medyczne Neuromed Sp. z.o.o.
RECRUITING
Bydgoszcz
NEURO-CARE Sp. z o.o. Sp. Komandytowa
RECRUITING
Katowice
ETG Neuroscience Sp. z o.o.
RECRUITING
Warsaw
NZOZ WCA
RECRUITING
Wroc?aw
Spain
Policlínica Guipuzcoa
RECRUITING
Donostia / San Sebastian
Hospital Quiron de Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario Dr. Peset
RECRUITING
Valencia
Taiwan
Kaohsiung Medical University Hospital
RECRUITING
Kaohsiung City
Taipei Medical University ?Shuang Ho Hospital
RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
North Dist.
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation Linkou Branch
RECRUITING
Taoyuan
United Kingdom
Lynfield Mount hospital
RECRUITING
Bradford
Recognition Health Bristol
RECRUITING
Bristol
Surrey and Borders NHS Foundation Trust
RECRUITING
Chertsey
Charing Cross Hospital
RECRUITING
London
Department of Old Age Psychiatry Kings College
RECRUITING
London
RE:Cognition Health
RECRUITING
London
Campus for Ageing & Vitality
RECRUITING
Newcastle
Tees,Esk and Wear Valleys NHS Foundation Trust
RECRUITING
York
Contact Information
Primary
Reference Study ID Number: WN45443 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2025-09-17
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