Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia
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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 |
- Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus). [ Time Frame: 6,12,18, 24 weeks. ] [ Designated as safety issue: No ]
- 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 |
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| Philippines | |
| Memory Center | |
| Quezon, Manila, Philippines | |
| Subic Bay Medical Center | |
| Olongapo, Zambales, Philippines | |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013