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A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1600
Start Date
2026-11-30
Completion Date
2032-09-03
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Trontinemab
Participants will receive IV trontinemab.
Placebo
Participants will receive IV placebo.
Locations (34)
Irvine Center for Clinical Research
Irvine, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Oakland Clinical
Oakland, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Conquest Research - Lake Nona
Orlando, Florida, United States
Charter Research - Lady Lake/The Villages
The Villages, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Basil Clinical
Laurelton, New York, United States
Sana Research, LLC
Arlington, Virginia, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
Kelowna Health and Memory Centre Ltd.
Kelowna, British Columbia, Canada
Toronto Memory Program
Toronto, Ontario, Canada
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Nanjing First Hospital
Nanjing, China
The Second Affiliated Hospital of Suzhou University
Suzhou, China
Taipei Veterans General Hospital
Taipei, Taiwan
Scottish Brain Sciences
Aberdeen, United Kingdom
Re:Cognition Health Birmingham
Birmingham, United Kingdom
Surrey and Borders NHS Foundation Trust
Chertsey, United Kingdom
Scottish Brain Sciences
Edinburgh, United Kingdom
Re:Cognition Health London
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
Moorgreen Hospital
Southampton, United Kingdom