NCT00663936

Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: FUJIFILM Toyama Chemical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	T-817MA	224 mg T-817 MA once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2008-04-22
• Last updated: 2013-11-05

Locations

35 sites across 2 countries: United States, Canada