Back to resultsOpen Label Study of TRx0014 in Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TRx0014
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
30mg tid TRx0014
60mg tid TRx0014
Outcomes
Primary Outcome Measures
Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
Secondary Outcome Measures
Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).
Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684944
Brief Title
Open Label Study of TRx0014 in Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 13, 2007 (Actual)
Primary Completion Date
December 2, 2010 (Actual)
Study Completion Date
December 2, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TauRx Therapeutics Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
30mg tid TRx0014
Arm Title
2
Arm Type
Active Comparator
Arm Description
60mg tid TRx0014
Intervention Type
Drug
Intervention Name(s)
TRx0014
Intervention Description
Gelatin capsule, tid
Primary Outcome Measure Information:
Title
Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).
Time Frame
0, 26 and 52 weeks
Secondary Outcome Measure Information:
Title
Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).
Time Frame
0, 26 and 52 weeks
Title
Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)
Time Frame
0, 26 and 52 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bentham, MRCPsych
Organizational Affiliation
Queen Elizabeth Psychiatric Hospital, United Kingdom
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Open Label Study of TRx0014 in Alzheimer's Disease
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