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

This study is currently recruiting participants.
Verified by Eisai Medical Research Inc., September 2005

Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165763
  Purpose

To examine the efficacy and safety of cholinesterase inhibitors (Donepezil hydrochloride) Aricept in patients with VaD.


Condition Intervention Phase
Vascular Dementia
Drug: DONEPEZIL HYDROCHLORIDE
Phase IV

MedlinePlus related topics:   Dementia   

Drug Information available for:   Donepezil    E 2020   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • CIBIC-plus, VaDAS-cog

Secondary Outcome Measures:
  • MMSE, CDR-SB, NPI

Study Start Date:   September 2005

  Eligibility
Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both

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 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

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

Contacts
Contact: Yukihiko Yokobatake     y-yokobatake@hhc.eisai.co.jp    

Locations
Philippines, Manila
Memory Center     Recruiting
      Quezon, Manila, Philippines
Philippines, Zambales
St. Luke's Medical Center     Recruiting
      Olongapo, Zambales, Philippines

Sponsors and Collaborators
Eisai Limited

Investigators
Study Chair:     Jacqueline Dominguez     Memory Center, St. Luke's Medical Center    
  More Information


Study ID Numbers:   AS-005 (ART-MNL-05-02)
First Received:   September 12, 2005
Last Updated:   September 22, 2005
ClinicalTrials.gov Identifier:   NCT00165763
Health Authority:   Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:
Arterial Occlusive Diseases
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Cognition Disorders
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Dementia, Vascular
Dementia
Delirium

Additional relevant MeSH terms:
Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Diseases
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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