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

NCT ID: NCT02434666

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-08

Study Completion Date

2016-11-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Dementia of the Alzheimer's Type

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPC-201

Group Type EXPERIMENTAL

CPC-201

Intervention Type DRUG

Interventions

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CPC-201

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minako Koga

Role: STUDY_DIRECTOR

Chase Pharmaceuticals

Locations

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Miami Jewish Health Systems

Miami, Florida, United States

Site Status

Quantum Laboratories, Inc. Memory Disorder Center

Pompano Beach, Florida, United States

Site Status

Premiere Research Institute Neuroscience

West Palm Beach, Florida, United States

Site Status

IU School of Medicine IU Health Neuroscience Center

Indianapolis, Indiana, United States

Site Status

Giles Cromwell, MD

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CPC-001-10

Identifier Type: -

Identifier Source: org_study_id