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

This study has been completed.
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165763
First received: September 12, 2005
Last updated: May 2, 2012
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Vascular Dementia
Drug: donepezil hydrochloride (Aricept)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study on the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus). [ Time Frame: 6,12,18, 24 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog). [ Time Frame: 6,12,18, 24 weeks. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2005
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165763

Locations
Philippines
Memory Center
Quezon, Manila, Philippines
Subic Bay Medical Center
Olongapo, Zambales, Philippines
Sponsors and Collaborators
Eisai Inc.
Eisai Co., Ltd.
Investigators
Study Chair: Jacqueline Dominguez Memory Center, St. Luke's Medical Center
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00165763     History of Changes
Other Study ID Numbers: AS-005 (ART-MNL-05-02)
Study First Received: September 12, 2005
Last Updated: May 2, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Eisai Inc.:
Vascular Dementia

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Vascular Diseases
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014