A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type

Exclusion Criteria

• •1. Women of child bearing potential.
• •2. History or presence of a seizure disorder.
• •3. Current unstable peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
• •4. History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
• •5. History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• •6. Renal and hepatic dysfunction with:
• •* Total Bilirubin: \>1.5 x UNL
• •* AST: \>2.5 x UNL
• •* ALT: \>2.5 x UNL
• •* Serum Creatinine: \>1.5 x UNL
• •* Creatinine Clearance: \<30 mL/min (calculated by Cockcroft and Gault equation)
• •7. History or presence of myasthenia.
• •8. History or family history of Prolonged QT Syndrome.
• •9. History of unexplained syncope or family history of unexplained syncope or sudden death.
• •10. Myocardial infarction or hospitalization for congestive heart failure within 6 months.
• •11. ECG findings of:
• •* Complete Left Bundle Branch Block;
• •* Ventricular pacing;
• •* 2nd degree or 3rd degree AV block;
• •* Atrial fibrillation or atrial flutter;
• •* HR \<45 or \>100;
• •* PR \>220 msec; or
• •* QTcF \>450 msec in male, \>470 msec in female
• •12. Known hypersensitivity to donepezil, solifenacin or related drugs.
• •13. History of drug significant allergy.
• •14. History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol.
• •15. Patients treated with the following medications within 8 weeks of screening
• •* AChEIs (other than donepezil),
• •* Peripherally acting anticholinergics (such as drugs for the treatment of overactive bladder disorder),
• •* Psychoactive medications (including antipsychotics, antidepressants, anxiolytics or sedative hypnotics) having significant anticholinergic effects and/or believed to affect cognitive function.
• •Other medications are acceptable, at the investigators discretion, if dosage is held stable for at least 4 weeks prior to screening and throughout the study.
• •16. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
• •17. Patients hospitalized within 4 weeks of screening.
• •18. Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
• •19. Patients who have participated in another clinical trial with an investigational drug within previous 30 days.