Dementia of the Alzheimer's Type Clinical Trial
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
This is a long-term-safety roll-over extension study for a Phase II Study (Protocol CPC-001-07).
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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