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
Running, not enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Alzheimers Disease
In brief
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.
Key facts
- Study ID
- NCT04639050
- Run by
- Hoffmann-La Roche
- People needed
- 241
- Starts
- 2021-03-15
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-06-16
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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