Open Label Study of TRx0014 in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684944
• Other study ID #: TRx-014-009
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2008
• Last updated: April 25, 2018
• Start date: September 13, 2007
• Est. completion date: December 2, 2010

Study information

• Verified date: April 2018
• Source: TauRx Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2, 2010
• Est. primary completion date: December 2, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Exclusion Criteria:

• There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• TRx0014
Gelatin capsule, tid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TauRx Therapeutics Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).		0, 26 and 52 weeks
Secondary	Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).		0, 26 and 52 weeks
Secondary	Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)		0, 26 and 52 weeks