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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPC-201
Sponsored by
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CPC1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPC-201

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Subjects With Any TEAEs
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
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.

Full Information

First Posted
July 7, 2014
Last Updated
May 11, 2020
Sponsor
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT02185053
Brief Title
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 31, 2014 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPC-201
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CPC-201
Primary Outcome Measure Information:
Title
Donepezil Maximum Tolerated Dose (MTD)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Subjects With Any TEAEs
Description
Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
Time Frame
6 months
Title
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
Description
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.
Time Frame
Day 1 (baseline) to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn James
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
CPC1
City
West Palm Beach
State/Province
Florida
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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