Trials / Terminated
TerminatedNCT02586909
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,099 (actual)
- Sponsor
- Axovant Sciences Ltd. · Industry
- Sex
- All
- Age
- 50 Years – 86 Years
- Healthy volunteers
- Not accepted
Summary
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
Detailed description
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RVT-101 35 mg tablets | once daily, oral tablets |
Timeline
- Start date
- 2016-04-26
- Primary completion
- 2018-03-12
- Completion
- 2018-03-12
- First posted
- 2015-10-27
- Last updated
- 2020-04-17
- Results posted
- 2020-04-17
Locations
169 sites across 19 countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Poland, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02586909. Inclusion in this directory is not an endorsement.