Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
|ClinicalTrials.gov Identifier: NCT02434666|
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dementia of the Alzheimer's Type||Drug: CPC-201||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 8, 2015|
|Actual Primary Completion Date :||October 18, 2016|
|Actual Study Completion Date :||November 22, 2016|
- safety and tolerability of the maximum tolerated dose (MTD) of CPC-201 (adverse events) [ Time Frame: 6 months ]To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
- safety and tolerability of CPC-201 20mg/day (adverse events) [ Time Frame: 6 months ]To evaluate the safety labs and adverse events from baseline, during the study and at the end of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434666
|United States, Florida|
|Miami Jewish Health Systems|
|Miami, Florida, United States, 33137|
|Quantum Laboratories, Inc. Memory Disorder Center|
|Pompano Beach, Florida, United States, 33064|
|Premiere Research Institute Neuroscience|
|West Palm Beach, Florida, United States, 33407|
|United States, Indiana|
|IU School of Medicine IU Health Neuroscience Center|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|Giles Cromwell, MD|
|Winston-Salem, North Carolina, United States, 27103|
|Study Director:||Minako Koga||Chase Pharmaceuticals|