A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease

Exclusion Criteria

• •Patients who meet any of the following criteria will be excluded:
• •1. Anti-dementia drug therapy (cholinesterase inhibitors or memantine) within 12 weeks prior to Screening.
• •2. Clinical and/or radiological evidence for other serious degenerative neurological disorders or neuropsychiatric disorders.
• •3. Known human immunodeficiency virus disease, neurosyphilis, or a history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities.
• •4. Hypothyroidism at Screening.
• •5. Vitamin B12 or folate deficiency at Screening.
• •6. Evidence of a new transient ischemic attack (TIA) or stroke that occurs within 12 weeks prior to Screening, even if the symptoms are minor and do not require hospitalization, are excluded.
• •7. Supine diastolic blood pressure ≥ 95 mmHg.
• •8. Complication of sick sinus syndrome, abnormal auricular and atrioventricular (AV) junction conductions (AV block, ≥ II ventricular block, etc.), or with a prolonged QT/QTc interval (\> 450 ms) as demonstrated by a repeated electrocardiogram (ECG).
• •9. A history of life-threatening arrhythmias.
• •10. A history of malignant neoplasms treated within 5 years prior to study entry, current evidence of malignant neoplasm, recurrent, or metastatic disease.
• •11. A known or suspected history of drug or alcohol dependency or abuse.
• •12. Abnormal clinical laboratory values which are judged clinically significant by the investigator.
• •13. Patients who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed.
• •14. Known plan for elective surgery that would require general anesthesia and administration of neuromuscular blocking agents.
• •15. Pregnant women, lactating women, or women of child-bearing potential who don't agree to practice effective contraception throughout the entire study period and for 30 days after donepezil discontinuation, or who don't have a negative serum â-Human chorionic gonadotropin (HCG) test result or a negative urine pregnancy test result.