TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation will be made at 24 weeks.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Enrollment: 323
Study Start Date: August 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator: 1 (Placebo: 0 milligrams; t.i.d.)
- Active Comparator: 2 (Treatment group: 30 milligrams; t.i.d.)
- Active Comparator: 3 (Treatment group: 60 milligrams; t.i.d.)
- Active Comparator: 4 (Treatment group: 100 milligrams; t.i.d.)


Related journal: Tau aggregation inhibitor therapy: an exploratory phase 2 study in mild or moderate Alzheimer's disease.