Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Last updated: May 2, 2012
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

4

Condition

Dementia

Alzheimer's Disease

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00165763
AS-005 (ART-MNL-05-02)
  • Ages 40-60
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 NeurologicalDisorders and Stroke and the Association Internationale pour la Recherche et l'Enseignementen Neurosciences International Workshop (NINCDS-AIREN). Subjects shall undergo extensiveclinical examination by a stroke specialist and radiological examination (CT or MRI) todocument presence of cerebrovascular disease. The clinical diagnosis has to be relevant tothe imaging findings. Other Inclusion criteria: Subjects with clinically stable hypertension, diabetes mellitus, and cardiac disease forthe last 3 months. Subjects with history of recent stroke, who have not been hospitalizedfor 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

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 psychiatricdisorders. 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, cholinomimeticand anticholinergic agents.

Study Design

Total Participants: 36
Study Start date:
September 01, 2005
Estimated Completion Date:

Study 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.

Connect with a study center

  • Memory Center

    Quezon, Manila
    Philippines

    Site Not Available

  • Subic Bay Medical Center

    Olongapo, Zambales
    Philippines

    Site Not Available

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