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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Control
  • DRUG TRx0237 16 mg/day
  • DRUG TRx0237 8 mg/day

Trial Details

FieldValue
Enrollment Target 598 participants
Start Date 2017-12-01
Est. Completion 2023-04-04
Phase Phase 3

Sponsor

TauRx Therapeutics

5 total trials

What the Registry Record Tells You About NCT03446001

The ClinicalTrials.gov registry entry for NCT03446001 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 598 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TauRx Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.

NCT03446001 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.