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

Vascular Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165763
• Other study ID #: AS-005 (ART-MNL-05-02)
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: May 2, 2012
• Start date: September 2005

Study information

• Verified date: September 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

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.

Locations

Country	Name	City	State
Philippines	Subic Bay Medical Center	Olongapo	Zambales
Philippines	Memory Center	Quezon	Manila

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Eisai Co., Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus).		6,12,18, 24 weeks.	No
Secondary	Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog).		6,12,18, 24 weeks.	No