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Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434666
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

Brief Summary:
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).

Condition or disease Intervention/treatment Phase
Dementia of the Alzheimer's Type Drug: CPC-201 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: CPC-201 Drug: CPC-201



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Have safely completed 12 week maintenance phase of CPC-001-07 study.

Exclusion Criteria:

  1. 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)

  2. History or presence of myasthenia.
  3. 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

  4. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434666


Locations
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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
Sponsors and Collaborators
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
Investigators
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Study Director: Minako Koga Chase Pharmaceuticals
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Responsible Party: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02434666    
Other Study ID Numbers: CPC-001-10
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases