NCT03446001

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: TauRx Therapeutics Ltd · Industry
• Sex: All
• Age: 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-03-31
• Completion: 2023-04-04
• First posted: 2018-02-26
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

103 sites across 8 countries: United States, Belgium, Canada, France, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study