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

Inclusion Criteria

• Signed an Institutional Review Board (IRB) approved informed consent document
• Aged 50 - 89 years inclusive.
• Meeting the diagnosis of probable AD consistent with:
• Revised National Institute on Aging-Alzheimer's Disease Association (NIA-ADA) criteria and
• Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria.
• Mild to severe severity (Mini-Mental Status Exam [MMSE] scores 7 - 24 inclusive).
• Rosen-Modified Hachinski Ischemia Score of ≤4.
• Have a suitable caregiver to supervise the at-home administration of study drugs and observe for AEs.
• Patients treated with donepezil 5 or 10 mg/day (given once daily) for at least 4 weeks just prior to Day1 for Population (group) 1 or;
• Patients never been treated with donepezil before (donepezil naïve) or who have not received any other AChEI for the past 6 months for Population (group) 2.
• Patients in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.

Exclusion Criteria

• Women of child bearing potential.
• History or presence of a seizure disorder.
• Current unstable peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
• History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
• History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• 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: 100;
• PR >220 msec; or
• QTcF >450 msec in male, >470 msec in female
• Known hypersensitivity to donepezil, solifenacin or related drugs.
• History of drug significant allergy.
• History of substance abuse, known drug addiction, or positive test for drugs of abuse or alcohol.
• 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.

• Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
• Patients hospitalized within 4 weeks of screening.
• 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.
• Patients who have participated in another clinical trial with an investigational drug within previous 30 days.