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Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment

NCT03446001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2025-09-04

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

TRx0237 16 mg/day

Oral TRx0237 4-mg tablets administered twice daily

DRUG

Control

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

DRUG

TRx0237 8 mg/day

Oral TRx0237 4-mg tablet administered twice daily

Sponsors & Collaborators

  • TauRx Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2022-03-31
Completion
2023-04-04
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446001 on ClinicalTrials.gov