Trials / Completed
CompletedNCT01656525
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gantenerumab | 75 mg subcutaneous doses every 4 weeks for 24 weeks |
| DRUG | Gantenerumab | 105 mg subcutaneous doses every 4 weeks for 24 weeks |
| DRUG | Gantenerumab | 225 mg subcutaneous doses every 4 weeks for 24 weeks |
| DRUG | Placebo | subcutaneous doses every 4 weeks for 24 weeks |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-03-01
- Completion
- 2014-06-01
- First posted
- 2012-08-03
- Last updated
- 2014-09-19
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01656525. Inclusion in this directory is not an endorsement.