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

NCT00165763 | Completed Phase 4 DMC

• 1 other identifier: AS-005 (ART-MNL-05-02)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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).

Conditions

Vascular Dementia

Keywords

Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus).

  6,12,18, 24 weeks.

Secondary Outcomes (1)

• Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog).

  6,12,18, 24 weeks.

Study Arms (1)

1

EXPERIMENTAL

Drug: donepezil hydrochloride (Aricept)

Interventions

donepezil hydrochloride (Aricept) DRUG

5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.

Also known as: Aricept

1

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Co., Ltd.: collaborator

Study Sites (2)

Memory Center

Quezon, Manila, Philippines

Location

Subic Bay Medical Center

Olongapo City, Zambales, Philippines

Location

MeSH Terms

Conditions

Dementia, Vascular

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Jacqueline Dominguez

  Memory Center, St. Luke's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2009
• Last Updated: May 4, 2012

Record last verified: 2009-09

Locations

PH (2)