A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia

Phase 2

Completed

Lead Sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CPC-201	CPC-201	-

Primary Outcome Measures

Name	Time	Method
Donepezil Maximum Tolerated Dose (MTD)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Any TEAEs	6 months	Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose	Day 1 (baseline) to end of 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.