Open Label Study of TRx0014 in Alzheimer's Disease

NCT ID: NCT00684944

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-13

Study Completion Date

2010-12-02

Brief Summary

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This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

30mg tid TRx0014

Group Type ACTIVE_COMPARATOR

TRx0014

Intervention Type DRUG

Gelatin capsule, tid

2

60mg tid TRx0014

Group Type ACTIVE_COMPARATOR

TRx0014

Intervention Type DRUG

Gelatin capsule, tid

Interventions

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TRx0014

Gelatin capsule, tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The 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. The carer must provide written consent to his or her own participation in the study.
* Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
* The patient must have been ongoing in TRx-014-001 at time of study termination.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TauRx Therapeutics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Bentham, MRCPsych

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Psychiatric Hospital, United Kingdom

Other Identifiers

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TRx-014-009

Identifier Type: -

Identifier Source: org_study_id

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