A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 80
Healthy Volunteers: f
View:
• Body weight of 150 kg or less
• Willingness and ability to complete all aspects of the study for the duration of the study
• Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
• Cognitively and functionally unimpaired as defined by the protocol
• Availability of a study partner as defined by the protocol
• A plasma pTau217 level consistent with a high likelihood of future clinical progression
Locations
United States
California
Irvine Center for Clinical Research
RECRUITING
Irvine
Healthy Brain Clinic
RECRUITING
Long Beach
Oakland Clinical
RECRUITING
Oakland
Syrentis Clinical Research
RECRUITING
Santa Ana
Florida
K2 Medical Research, LLC
RECRUITING
Maitland
Renstar Medical Research
RECRUITING
Ocala
Charter Research - Winter Park/Orlando
RECRUITING
Orlando
Conquest Research - Lake Nona
RECRUITING
Orlando
Charter Research - Lady Lake/The Villages
RECRUITING
The Villages
Conquest Research, LLC
RECRUITING
Winter Park
New York
Basil Clinical
RECRUITING
Laurelton
Virginia
Sana Research, LLC
RECRUITING
Arlington
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
KaRa Institute of Neurological Diseases
RECRUITING
Macquarie Park
Canada
Kelowna Health and Memory Centre Ltd.
RECRUITING
Kelowna
Toronto Memory Program
RECRUITING
Toronto
China
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
The second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University
RECRUITING
Hangzhou
Nanjing First Hospital
RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Suzhou University
RECRUITING
Suzhou
Yan'an University Xianyang Hospital
RECRUITING
Xianyang
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Scottish Brain Sciences
RECRUITING
Aberdeen
Re:Cognition Health Birmingham
RECRUITING
Birmingham
Surrey and Borders NHS Foundation Trust
RECRUITING
Chertsey
Scottish Brain Sciences
RECRUITING
Edinburgh
Charing Cross Hospital
RECRUITING
London
Re:Cognition Health London
RECRUITING
London
Moorgreen Hospital
RECRUITING
Southampton
Contact Information
Primary
Reference Study ID Number: WN46072 https://forpatients.roche.com
global-roche-genentech-trials@gene.com
1-888-662-6728
Time Frame
Start Date:2026-11-30
Estimated Completion Date:2032-09-03
Participants
Target number of participants:1600
Treatments
Experimental: Trontinemab
Participants will receive intravenous (IV) trontinemab.