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 (47) 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
California
Healthy Brain Clinic
RECRUITING
Long Beach
Riverside Clinical
RECRUITING
Riverside
Cenexel California Neuroscience Research, LLC
RECRUITING
Sherman Oaks
Florida
JEM Research LLC
RECRUITING
Atlantis
K2 Medical Research-Winter Garden
RECRUITING
Clermont
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
Massachusetts
Adams Clinical Watertown
RECRUITING
Watertown
New Jersey
The Cognitive and Research Center of New Jersey
RECRUITING
Springfield
Oregon
Summit Research Network Inc.
RECRUITING
Portland
Pennsylvania
Flourish Research ? Philadelphia
RECRUITING
Plymouth Meeting
Texas
Kerwin Medical Center
RECRUITING
Dallas
Mt.Olympus Medical Research
RECRUITING
Katy
Virginia
Re:Cognition Health
RECRUITING
Fairfax
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
Royal Prince Alfred Hospital
RECRUITING
Camperdown
KaRa Institute of Neurological Diseases
RECRUITING
Macquarie Park
Canada
Okanagan Clinical Trials
RECRUITING
Kelowna
Kawartha Centre - Redefining Healthy Aging
RECRUITING
Peterborough
France
Groupement Hospitalier Est - Hôpital Neurologique
RECRUITING
Bron
CHU de Rouen Hopital
RECRUITING
Rouen
Germany
Ambulates Gesundheitszentrum der Charité GmbH
RECRUITING
Berlin
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
RECRUITING
Berlin
Universitätsklinikum Köln
RECRUITING
Cologne
Japan
Brain Attack Center Ota Memorial Hospital
RECRUITING
Hiroshima
National Hospital Organization Hiroshima-Nishi Medical Center
RECRUITING
Hiroshima
Kobe University Hospital
RECRUITING
Hyōgo
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
Poland
Podlaskie Centrum Psychogeriatrii
RECRUITING
Bia?ystok
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
RECRUITING
Sopot
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Ewha Womans University Hospital (Seoul)
RECRUITING
Seoul
Spain
Fundación ACE
RECRUITING
Barcelona
United Kingdom
ReMind UK
RECRUITING
Bath
Re:Cognition Health Birmingham
RECRUITING
Birmingham
Scottish Brain Sciences
RECRUITING
Edinburgh
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
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