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

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

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

Study Overview

• Status: Completed
• Conditions: Vascular Dementia
• Intervention / Treatment: Drug: donepezil hydrochloride (Aricept)

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • Manila
    • Quezon, Manila, Philippines
      • Memory Center
  • Zambales
    • Olongapo, Zambales, Philippines
      • Subic Bay Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: donepezil hydrochloride (Aricept); 5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.; Other Names: Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus).	6,12,18, 24 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog).	6,12,18, 24 weeks.

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Eisai Co., Ltd.
• Investigators: Study Chair: Jacqueline Dominguez, Memory Center, St. Luke's Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): May 4, 2012
• Last Update Submitted That Met QC Criteria: May 2, 2012
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Vascular Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Dementia, Vascular; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: AS-005 (ART-MNL-05-02)