Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

Dementia Associated With Cerebrovascular Disease Clinical Trial

Official title:

Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188812
• Other study ID #: 03-0725-AE
• Secondary ID: E2020-A001-320
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 9, 2009
• Start date: May 2004
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

one year extension study following a previous double-blind study to evaluate safety of the drug

Description:

A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• must have completed previous study E2020-A001-319

Exclusion Criteria:

• absence of a reliable caregiver

• clinically significant medical condition

• recent TIA

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Dementia
• Dementia Associated With Cerebrovascular Disease

Intervention

Drug:
• donepezil hcl

Locations

Country	Name	City	State
Canada	Toronto Western Hopital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Eisai Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety assessments