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drugset / Trial / NCT03446001

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

NCT03446001 ↗

Phase 3 Completed 598 enrolled TauRx Therapeutics Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-12-01
Primary completion
2022-03-31
Completion
2023-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HYDROMETHYLTHIONINE Small molecule 8 mg Oral
Subject HYDROMETHYLTHIONINE Small molecule 16 mg Oral

Indications

Alzheimer disease