Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

NCT ID: NCT00188812

Last Updated: 2009-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2005-08-31

Brief Summary

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

Detailed 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.

Conditions

Dementia Associated With Cerebrovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

donepezil hcl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• must have completed previous study E2020-A001-319

Exclusion Criteria

• absence of a reliable caregiver
• clinically significant medical condition
• recent TIA

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Karl Farcnik, MD FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hopital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

E2020-A001-320

Identifier Type: -

Identifier Source: secondary_id

03-0725-AE

Identifier Type: -

Identifier Source: org_study_id