NCT00188812

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

January 12, 2009

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

January 9, 2009

Conditions

Dementia Associated With Cerebrovascular Disease

Keywords

dementiastroke

Outcome Measures

Primary Outcomes (1)

  • safety assessments

Interventions

donepezil hclDRUG

Eligibility Criteria

Age45 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must have completed previous study E2020-A001-319

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hopital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

DementiaStroke

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Karl Farcnik, MD FRCP(C)

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Study Completion

August 1, 2005

Last Updated

January 12, 2009

Record last verified: 2005-09

Locations

CA(1)