Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00188812

Enrollment

Unknown

Registered

2005-09-16

Start date

2004-05-31

Completion date

2005-08-31

Last updated

2009-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia Associated With Cerebrovascular Disease

Keywords

dementia, stroke

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.

Interventions

DRUGdonepezil hcl

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Inclusion criteria

* must have completed previous study E2020-A001-319

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety assessments	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026