NCT01723826

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Crenezumab	Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.

Timeline

• Start date: 2012-12-07
• Primary completion: 2017-02-08
• Completion: 2017-02-08
• First posted: 2012-11-08
• Last updated: 2020-02-20
• Results posted: 2020-02-12

Locations

86 sites across 6 countries: United States, Canada, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study