CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 598 enrolled
Drug / intervention
TRx0237 16 mg/day +2 moredrug
Likely dose
TRx0237 16 mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03446001
NCT03446001Phase 3Completed
CompareCT.gov

Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment

TauRx Therapeutics Ltd·interventional·Posted Feb 26, 2018·Updated Sep 4, 2025

In Brief

A Phase 3 clinical trial evaluating TRx0237 16 mg/day, Control, and 1 other intervention for Alzheimer Disease. Completed, enrolled 598 participants across 103 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesBelgium, Canada, France, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 26, 2018
Enrollment StartDec 1, 2017
Primary CompletionMar 31, 2022
Study CompletionApr 4, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.3 years ago

Interventions

TRx0237 16 mg/daydrug

Oral TRx0237 4-mg tablets administered twice daily

Controldrug

Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily

TRx0237 8 mg/daydrug

Oral TRx0237 4-mg tablet administered twice daily