NCT02353598

A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease

A Phase Ib, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Arm, Multiple-Dose Study to Assess The Safety, Tolerability, And Pharmacokinetics of Intravenous Crenezumab Administered in Patients With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72 participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination \[MMSE\] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered after the completion of initial double-blind stage.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Crenezumab dose level 1	Participants will receive crenezumb dose level 1 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
DRUG	Crenezumab dose level 2	Participants will receive crenezumb dose level 2 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
DRUG	Crenezumb dose level 3	Participants will receive crenezumb dose level 3 IV infusion once every 4 weeks upto Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
DRUG	Placebo	Participants will receive placebo matched to crenezumab IV infusion once every 4 weeks upto Week 13 in double-blind treatment window.

Timeline

• Start date: 2015-02-26
• Primary completion: 2016-11-30
• Completion: 2019-03-26
• First posted: 2015-02-03
• Last updated: 2019-07-24

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study