Trials / Completed
CompletedNCT01689246
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 891 (actual)
- Sponsor
- TauRx Therapeutics Ltd · Industry
- Sex
- All
- Age
- 89 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild to moderate Alzheimer's Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TRx0237 150 mg/day | TRx0237 75 mg tablets will be administered twice daily. |
| DRUG | TRx0237 250 mg/day | TRx0237 125 mg tablets will be administered twice daily. |
| DRUG | Placebo | Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2012-09-21
- Last updated
- 2018-03-14
Locations
121 sites across 16 countries: United States, Australia, Bulgaria, Canada, Croatia, Germany, Italy, Malaysia, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01689246. Inclusion in this directory is not an endorsement.