NCT02434666

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia of the Alzheimer's Type

Interventions

Type	Name	Description
DRUG	CPC-201

Timeline

• Start date: 2015-01-08
• Primary completion: 2016-10-18
• Completion: 2016-11-22
• First posted: 2015-05-05
• Last updated: 2017-09-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study