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Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

Primary Purpose

Dementia Associated With Cerebrovascular Disease

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

donepezil hcl

About this trial

This is an interventional treatment trial for Dementia Associated With Cerebrovascular Disease focused on measuring dementia, stroke

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: must have completed previous study E2020-A001-319 Exclusion Criteria: absence of a reliable caregiver clinically significant medical condition recent TIA

Sites / Locations

Toronto Western Hopital

Outcomes

Primary Outcome Measures

safety assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT00188812

First Posted

September 12, 2005

Last Updated

January 9, 2009

Sponsor

University Health Network, Toronto

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00188812

Brief Title

Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

Collaborators

Eisai Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia Associated With Cerebrovascular Disease

Keywords

dementia, stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

donepezil hcl

Primary Outcome Measure Information:

Title

safety assessments

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Farcnik, MD FRCP(C)

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Western Hopital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

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