An Open Label Study on the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Eisai Inc.2 sites in 1 country36 target enrollmentSeptember 2005

ConditionsVascular Dementia

Interventionsdonepezil hydrochloride (Aricept)

Drugsdonepezil hydrochloride (Aricept)

Overview

Phase: Phase 4
Intervention: donepezil hydrochloride (Aricept)
Conditions: Vascular Dementia
Sponsor: Eisai Inc.
Enrollment: 36
Locations: 2
Primary Endpoint: Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus).
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).

Detailed Description

Vascular dementia is a significant cause of intellectual and functional impairment in young patients consequent to cerebrovascular disease. Post-mortem studies show that VaD patients have a cholinergic deficiency like in Alzheimer's disease (AD). Cholinesterase inhibitors are now standard treatment for mild to moderate AD. This study aims to determine if donepezil, a cholinesterase inhibitor, would benefit patients with VaD by decreasing their scores in the VaDAS-cog and improvement in their CIBIC rating over a period of 24-weeks treatment. Adverse events will also be monitored.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

September 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects eligible for this study are men and women outpatients, age 40-60 years old, who fulfill the criteria for VAD according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences International Workshop (NINCDS-AIREN). Subjects shall undergo extensive clinical examination by a stroke specialist and radiological examination (CT or MRI) to document presence of cerebrovascular disease. The clinical diagnosis has to be relevant to the imaging findings.
•Other Inclusion criteria:
•Subjects with clinically stable hypertension, diabetes mellitus, and cardiac disease for the last 3 months. Subjects with history of recent stroke, who have not been hospitalized for stroke in the previous 3 months. Subjects with depression controlled with medications. Subjects should have no hearing or visual impairment and live with a reliable caregiver.
•Exclusion criteria:
•Subjects should have no radiological evidence of other brain disorders (subdural hematoma, post-traumatic / post-surgery) have no depression or other psychiatric disorders, infectious disorders, neoplastic condition, and metabolic and toxic encephalopathies, dementia due to AD or prior diagnosis of AD, and major depression or other psychiatric disorders.
•Subjects with clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine or other life threatening diseases; pregnancy, history of alcohol or drug abuse, and sensitivity to cholinesterase inhibitors; use of investigational agents, cholinomimetic and anticholinergic agents.