Trials / Terminated
TerminatedNCT02670083
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 813 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Crenezumab | Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. |
| DRUG | Placebo | Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. |
Timeline
- Start date
- 2016-03-22
- Primary completion
- 2019-05-31
- Completion
- 2019-05-31
- First posted
- 2016-02-01
- Last updated
- 2020-07-16
- Results posted
- 2020-07-16
Locations
196 sites across 30 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Lithuania, Mexico, Poland, Portugal, Russia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02670083. Inclusion in this directory is not an endorsement.