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ACTIVE NOT RECRUITING
NCT04639050
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

RO7126209

RO7126209 will be administered intravenously as specified in each treatment arm.

DRUG

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