Clinical Trial: A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Brief Summary: This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Detailed Summary:
Sponsor: Eisai Inc.

Current Primary Outcome: Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Baseline, Week 6, Week 12 and Week 28. ]

Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)


Original Primary Outcome: Safety [ Time Frame: Baseline, Week 6, Week 12 and Week 28. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Eisai Inc.

Dates:
Date Received: May 14, 2009
Date Started: February 2006
Date Completion:
Last Updated: December 12, 2013
Last Verified: December 2013