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

Chase Pharmaceuticals Corporation, an affiliate of Allergan plc1 site in 1 country41 target enrollmentJuly 31, 2014

ConditionsAlzheimer's Disease

InterventionsCPC-201

DrugsCPC-201

Overview

Phase: Phase 2
Intervention: CPC-201
Conditions: Alzheimer's Disease
Sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
Enrollment: 41
Locations: 1
Primary Endpoint: Donepezil Maximum Tolerated Dose (MTD)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 31, 2014

End Date

July 31, 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

CPC-201

Intervention: CPC-201

Outcomes

Primary Outcomes

Donepezil Maximum Tolerated Dose (MTD)

Time Frame: 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 Outcomes

Number of Subjects With Any TEAEs(6 months)
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose(Day 1 (baseline) to end of study)