NCT00515333

TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: TauRx Therapeutics Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dementia, Alzheimer Type

Interventions

Type	Name	Description
DRUG	TRx0014	Hard capsule; 60 milligrams; t.i.d.
DRUG	TRx0014	Hard capsule; 30 milligrams; t.i.d.
DRUG	Placebo	Hard capsule; 0 milligrams; t.i.d.
DRUG	TRx0014	Hard capsule, 100 milligrams, t.i.d.

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-08-13
• Last updated: 2008-02-20