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

NCT ID: NCT02185053

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPC-201

Group Type: EXPERIMENTAL

CPC-201

Intervention Type: DRUG

Interventions

CPC-201

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn James

Role: STUDY_DIRECTOR

Allergan

Locations

CPC1

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

CPC-001-07

Identifier Type: -

Identifier Source: org_study_id