Who is sponsoring NCT03443973?

NCT03443973 is sponsored by Hoffmann-La Roche.

What condition does NCT03443973 study?

NCT03443973 studies Alzheimer Disease.

What drugs are being tested in NCT03443973?

Interventions: Gantenerumab, Placebo.

What is the status of NCT03443973?

NCT03443973 is currently TERMINATED.

Last reviewed 2024-01-17 · How we verify

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

NCT03443973 PHASE3 TERMINATED Results posted

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	TERMINATED
Enrolment	975
Start date	Wed Aug 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Nov 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Alzheimer Disease

Interventions

Gantenerumab
Placebo

Countries

Finland, Japan, Poland, South Korea, Croatia, Denmark, Netherlands, Belgium, Sweden, Mexico, Portugal, United States, Chile, Argentina, Puerto Rico, Spain, United Kingdom, Singapore, Turkey (Türkiye)