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

• Status: Completed
• Trial end date: 2016-11-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chase Pharmaceuticals Corporation; Chase Pharmaceuticals Corporation, an affiliate of Allergan plc

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.