TRx0014 in Patients With Mild or Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00515333|
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : February 20, 2008
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Alzheimer Type||Drug: TRx0014 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||323 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Placebo Comparator: 1
Placebo: 0 milligrams; t.i.d.
Hard capsule; 0 milligrams; t.i.d.
Active Comparator: 2
Treatment group: 30 milligrams; t.i.d.
Hard capsule; 30 milligrams; t.i.d.
Active Comparator: 3
Treatment group: 60 milligrams; t.i.d.
Hard capsule; 60 milligrams; t.i.d.
Active Comparator: 4
Treatment group: 100 milligrams; t.i.d.
Hard capsule, 100 milligrams, t.i.d.
- Cognitive ability (ADAS-cog) [ Time Frame: At 24 weeks ]
- Behavioural and psychological symptoms (NPI) [ Time Frame: At 12 and 24 weeks ]
- Global performance (ADCS-CGIC) [ Time Frame: At 12 and 24 weeks ]
- Dementia severity (CDR-sb) [ Time Frame: At 12 and 24 weeks ]
- Cognition (MMSE) [ Time Frame: At 12 and 24 weeks ]
- Dementia caseness (Short CAMDEX) [ Time Frame: At 12 and 24 weeks ]
- Cognitive function (ADAS-cog) [ Time Frame: At 6, 12, 18 and 24 weeks ]
- Daily activities of living (BADLS) [ Time Frame: At 12 and 24 weeks ]
- Changes in cerebral perfusion pattern (SPECT or PET) [ Time Frame: At baseline and between 24-26 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515333
|Study Chair:||Claude M Wischik, MBChB||TauRx Therapeutics Ltd|
|Principal Investigator:||Peter Bentham, MBChB||Queen Elizabeth Psychiatric Hospital, Birmingham, United Kingdom|