TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

February 19, 2008 updated by: TauRx Therapeutics Ltd

An Exploratory Placebo-Controlled, Dose-Ranging Study of the Effects of TRx0014 30 MG TID, 60 MG TID AND 100 MG TID in Patients With Mild or Moderate Dementia of the Alzheimer Type

The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation will be made at 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments.
  • Patients must be able to give written informed consent to participate in this study. Patients who lack capacity to consent may not be entered.
  • Competent carer must be available and must provide written consent to his or her own participation in the study.

  • Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and a diagnosis of Probable Alzheimer's Disease determined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. Information to support the diagnosis will include that derived from:

    • an abbreviated Cambridge Mental Disorders of the Elderly Examination (short CAMDEX) schedule, performed within six weeks prior to the baseline visit (Visit 0).
    • Computerised tomography (CT) or magnetic resonance imaging (MRI), with no time limit on previous scans. In centres conducting SPECT/PET scans as part of their routine practice or as part of the study these may be used to inform the NINCDS-ADRDA diagnosis.

  • Patient must have mild or moderate dementia as determined by:

    • Mini-Mental State Examination (MMSE) value at screening of between 10 and 26 inclusive.
    • Clinical Dementia Rating (CDR) at screening of Stage 1 or Stage 2.

Exclusion Criteria:

  • Patient has a known sensitivity to TRx0014, similar agents or any of the excipients used.
  • Screening blood sample shows that the patient has glucose-6-phosphate dehydrogenase deficiency.
  • Patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.
  • Patient has significant impairment of renal, hepatic or haematological function for the age of the patient.
  • Patient is currently taking other anti-dementia drugs (e.g. memantine, cholinesterase inhibitors) or has taken these within the previous six weeks.
  • It is anticipated that there will be a definite indication for the commencement of other licensed anti-dementia drug treatment within the 24 week treatment period of the trial.
  • Patient has started taking other medication known to have an effect on mood or cognition (e.g. anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics, antidepressants, antiepileptics) within the previous six weeks; or has changed their dose of these medications within the previous six weeks.
  • Patient has started taking 'alternative therapy' for AD e.g. vitamin E, folic acid, hormone replacement therapy (HRT), ginkgo biloba within the previous six weeks; or has changed their dose of these treatments within the previous six weeks.
  • Patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were elevated or fell due to interaction with TRx0014.
  • Patients who are unlikely to comply with trial visit schedule or with trial medication.
  • Significant intercurrent illness which may compromise safety of the patient/validity of the data.
  • Females with the potential of childbearing and are not using adequate contraception or females who are breastfeeding.
  • Patients with a history of alcohol and/or drug abuse, defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and/or any illicit drug, including cannabis within the last six months.
  • Patient has participated in a clinical investigation of a medication or device within the previous three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo: 0 milligrams; t.i.d.
Drug: Placebo
Hard capsule; 0 milligrams; t.i.d.
Active Comparator: 2
Treatment group: 30 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 60 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 30 milligrams; t.i.d.
Drug: TRx0014
Hard capsule, 100 milligrams, t.i.d.
Active Comparator: 3
Treatment group: 60 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 60 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 30 milligrams; t.i.d.
Drug: TRx0014
Hard capsule, 100 milligrams, t.i.d.
Active Comparator: 4
Treatment group: 100 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 60 milligrams; t.i.d.
Drug: TRx0014
Hard capsule; 30 milligrams; t.i.d.
Drug: TRx0014
Hard capsule, 100 milligrams, t.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive ability (ADAS-cog)
Time Frame: At 24 weeks
At 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Behavioural and psychological symptoms (NPI)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Global performance (ADCS-CGIC)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Dementia severity (CDR-sb)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Cognition (MMSE)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Dementia caseness (Short CAMDEX)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Cognitive function (ADAS-cog)
Time Frame: At 6, 12, 18 and 24 weeks
At 6, 12, 18 and 24 weeks
Daily activities of living (BADLS)
Time Frame: At 12 and 24 weeks
At 12 and 24 weeks
Changes in cerebral perfusion pattern (SPECT or PET)
Time Frame: At baseline and between 24-26 weeks
At baseline and between 24-26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TauRx Therapeutics Ltd

Investigators

  • Study Chair: Claude M Wischik, MBChB, TauRx Therapeutics Ltd
  • Principal Investigator: Peter Bentham, MBChB, Queen Elizabeth Psychiatric Hospital, Birmingham, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

February 20, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRx-014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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