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Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

NCT01689246 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 891

Last updated 2018-03-14

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild to moderate Alzheimer's Disease.

Conditions

Interventions

DRUG

TRx0237 150 mg/day

TRx0237 75 mg tablets will be administered twice daily.

DRUG

TRx0237 250 mg/day

TRx0237 125 mg tablets will be administered twice daily.

DRUG

Placebo

Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.

Sponsors & Collaborators

  • TauRx Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Croatia
  • Germany
  • Italy
  • Malaysia
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01689246 on ClinicalTrials.gov