NCT04639050

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-15
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2020-11-20
• Last updated: 2026-03-18

Locations

41 sites across 9 countries: United States, Australia, Canada, Chile, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study