NCT01626391

Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease

A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: TauRx Therapeutics Ltd · Industry
• Sex: All
• Age: 90 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	TRx0237	TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks
DRUG	Placebo	Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-06-22
• Last updated: 2014-07-11
• Results posted: 2014-07-11

Locations

12 sites across 2 countries: Germany, United Kingdom