A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
A Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients With Alzheimer's Disease Type Dementia
Lead SponsorChase Pharmaceuticals Corporation
StatusCompleted Results Posted
Intervention/Treatmentdonepezil solifenacin ...
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.
Inclusion Criteria: Aged 50 - 79 years inclusive. Meeting the diagnosis of probable Alzheimer's Disease Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive). Patients must be 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. History of 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. History or presence of myasthenia. Known hypersensitivity to donepezil, solifenacin or related drugs. 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.
|Event Type||Organ System||Event Term||Safety Population|
Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.