NCT03289143

A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Semorinemab	Participants will receive Semorinemab intravenously (IV).
DRUG	Placebo	Matching placebo doses of Semorinemab given intravenously (IV).
DRUG	[18F]GTP1	\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.

Timeline

• Start date: 2017-10-04
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2017-09-20
• Last updated: 2022-03-16
• Results posted: 2022-03-16

Locations

133 sites across 13 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study