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NCT03446001 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment
A Phase 3 study, sponsored by TauRx Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 598
- Enrollment target
NCT03446001: Completed Phase 3 study, sponsored by TauRx Therapeutics.
NCT03446001 is a Phase 3 study that has completed, run by TauRx Therapeutics. The registered enrollment target is 598 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446001, a Phase 3 study, has completed, sponsored by TauRx Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 598 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.
Primary Outcome
This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).
Interventions
- DRUG Control
- DRUG TRx0237 16 mg/day
- DRUG TRx0237 8 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 598 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 3 |
What the finished NCT03446001 record still lists
NCT03446001 is an interventional study that assigns participants to a tested intervention. The registered 598 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT03446001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03446001 about?
NCT03446001 is a clinical study titled "Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment". The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.
What is the current status of trial NCT03446001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 598 participants. The study started on 2017-12-01. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT03446001?
The interventions under investigation include: Control (DRUG), TRx0237 16 mg/day (DRUG), TRx0237 8 mg/day (DRUG).
Who is sponsoring clinical trial NCT03446001?
This trial is sponsored by TauRx Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03446001's enrollment target sits among peer trials
598 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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