Open Label Study of TRx0014 in Alzheimer's Disease
An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease
1 other identifier
interventional
111
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2007
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2010
CompletedApril 27, 2018
April 1, 2018
3.2 years
May 22, 2008
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).
0, 26 and 52 weeks
Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)
0, 26 and 52 weeks
Study Arms (2)
1
ACTIVE COMPARATOR30mg tid TRx0014
2
ACTIVE COMPARATOR60mg tid TRx0014
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Bentham, MRCPsych
Queen Elizabeth Psychiatric Hospital, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 28, 2008
Study Start
September 13, 2007
Primary Completion
December 2, 2010
Study Completion
December 2, 2010
Last Updated
April 27, 2018
Record last verified: 2018-04