Back to resultsLong Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
Primary Purpose
Dementia of the Alzheimer's Type
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CPC-201
Sponsored by
About this trial
This is an interventional treatment trial for Dementia of the Alzheimer's Type
Eligibility Criteria
Inclusion Criteria:
- Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
- Have safely completed 12 week maintenance phase of CPC-001-07 study.
Exclusion Criteria:
Renal and hepatic dysfunction with:
Total Bilirubin: >1.5 x UNL AST: >2.5 x UNL ALT: >2.5 x UNL Serum Creatinine: >1.5 x UNL Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation)
- History or presence of myasthenia.
ECG findings of:
Complete Left Bundle Branch Block; Ventricular pacing; 2nd degree or 3rd degree AV block; Atrial fibrillation or atrial flutter; HR <45 or >100; PR >220 msec; or QTcF >450 msec in male, >470 msec in female
- Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- 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.
Sites / Locations
- Miami Jewish Health Systems
- Quantum Laboratories, Inc. Memory Disorder Center
- Premiere Research Institute Neuroscience
- IU School of Medicine IU Health Neuroscience Center
- Giles Cromwell, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPC-201
Arm Description
Outcomes
Primary Outcome Measures
safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Secondary Outcome Measures
safety and tolerability of CPC-201 20mg/day (adverse events)
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Full Information
NCT ID
NCT02434666
First Posted
April 28, 2015
Last Updated
September 18, 2017
Sponsor
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
1. Study Identification
Unique Protocol Identification Number
NCT02434666
Brief Title
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
Official Title
Safety and Tolerability of CPC-201 in Patients With Dementia of the Alzheimer's Type Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2015 (Actual)
Primary Completion Date
October 18, 2016 (Actual)
Study Completion Date
November 22, 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
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).
Detailed Description
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07). Patients having safely completed the 12-week maintenance phase of Study CPC-001-07 will be eligible for admission. Subjects will remain on their CPC-201 MTD as determined in Study CPC-001-07. The dose of CPC-201 will be increased from 15 mg/day (administered in Study CPC-001-07) to 20mg/day starting on Day1. For those patients who do not tolerate 20mg/day CPC-201, the dose of CPC-201will be decreased to its previously tolerated level of 15mg/day.
This protocol allows to increase patients' MTD of CPC-201, as previously determined in the Phase II Study (CPC-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day starting on Day7 or Month 3 visits of this extension protocol per Investigator's judgment and patient's tolerability.
This extension study is intended to continue for each enrolled patient for up to 6 months unless medically contraindicated. Patients may withdraw from this study at any time. Upon termination of this study, patients will return to their original daily donepezil dose of 10 mg/day and will continue to receive CPC-201 mg/day for one final week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia of the Alzheimer's Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (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
safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events)
Description
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
safety and tolerability of CPC-201 20mg/day (adverse events)
Description
To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
Have safely completed 12 week maintenance phase of CPC-001-07 study.
Exclusion Criteria:
Renal and hepatic dysfunction with:
Total Bilirubin: >1.5 x UNL AST: >2.5 x UNL ALT: >2.5 x UNL Serum Creatinine: >1.5 x UNL Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation)
History or presence of myasthenia.
ECG findings of:
Complete Left Bundle Branch Block; Ventricular pacing; 2nd degree or 3rd degree AV block; Atrial fibrillation or atrial flutter; HR <45 or >100; PR >220 msec; or QTcF >450 msec in male, >470 msec in female
Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minako Koga
Organizational Affiliation
Chase Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Quantum Laboratories, Inc. Memory Disorder Center
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Premiere Research Institute Neuroscience
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
IU School of Medicine IU Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Giles Cromwell, MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
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