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Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
Official title: A Phase Ib/IIa, Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Patients With Prodromal or Mild to Moderate Alzheimer's Disease
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
241
Start Date
2021-03-15
Completion Date
2030-06-30
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
RO7126209
RO7126209 will be administered intravenously as specified in each treatment arm.
Placebo
RO7126209-matching placebo will be administered intravenously as specified in each treatment arm.
Locations (41)
JEM Research LLC
Atlantis, Florida, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Optimus U Corp
Miami, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
Charter Research - Lady Lake/The Villages
The Villages, Florida, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Summit Research Network Inc.
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Kerwin Research Center, LLC
Dallas, Texas, United States
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Richmond Clinical Trials
Richmond, British Columbia, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Centro de Investigación Clínica UC-CICUC
Santiago, Chile
Hospital Clinico Univ de Chile
Santiago, Chile
Yokohama City Minato Red Cross Hospital
Kanagawa, Japan
Koseikai Takeda Hospital
Kyoto, Japan
National Hospital Organization Utano National Hospital
Kyoto, Japan
Keio University Hospital
Tokyo, Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, Japan
Osrodek Badan Klinicznych Euromedis
Szczecin, Poland
NZOZ WCA
Wroc?aw, Poland
Inha University Hospital
Incheon, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Policlínica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain
Fundación ACE
Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Hospital Universitario la Fe
Valencia, Spain
UCL Institute of Neurology
London, United Kingdom