NCT03828747

A Study of Semorinemab in Patients With Moderate Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Semorinemab	Participants will receive semorinemab every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period. Semorinemab will be administered Q4W in the OLE period.
DRUG	Placebo	Participants will receive placebo every 2 weeks (Q2W) for the first three doses of the double-blind treatment period and every 4 weeks (Q4W) thereafter during the double-blind treatment period.
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: 2019-01-25
• Primary completion: 2021-07-20
• Completion: 2023-08-30
• First posted: 2019-02-04
• Last updated: 2024-09-24
• Results posted: 2022-10-03

Locations

49 sites across 4 countries: United States, France, Poland, Spain

Regulatory

• FDA-regulated drug study