MedTrace Logo

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

NCT01626391 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-07-11

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • TauRx Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Mark Dale, MD · MAC Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany
  • 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 NCT01626391 on ClinicalTrials.gov