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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: CPC-201

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States
      • CPC1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPC-201	Drug: CPC-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donepezil Maximum Tolerated Dose (MTD)	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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
• Investigators: Study Director: Lynn James, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2014
• Primary Completion (Actual): July 31, 2016
• Study Completion (Actual): July 31, 2016

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Disease; Dementia; Alzheimer Disease
• Other Study ID Numbers: CPC-001-07