NCT03114657

A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Crenezumab	Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
DRUG	Placebo	Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Timeline

• Start date: 2017-03-29
• Primary completion: 2019-06-11
• Completion: 2019-06-11
• First posted: 2017-04-14
• Last updated: 2020-07-16
• Results posted: 2020-07-16

Locations

211 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Israel, Italy, Japan, Norway, Peru, Poland, Portugal, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study