Dementia of Alzheimer's Type Clinical Trial
Official title:
A Phase II, Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type
This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's type to determine the optimal dose titration schedule.
This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's
type to determine the optimal dose titration schedule. The study involves a step wise cohort
design in two different patient populations: Group 1 will comprise of patients who have been
treated with low dose of CPC-201(5 or 10 mg/day) (given once daily) for at least 4 weeks just
prior to Day1. Group 2 will consist of patients who have never been treated with CPC-201
before or who have not received any other AChEI for the past 6 months.
In this study, CPC-201 dose will be increased at weekly intervals, in accordance with the
schedules given below, to its first intolerable dose (FID) or maximum allowed dose (MAD) of
60 mg/day (40mg/day for Cohort 3c) together with solifenacin 15 mg/day.
Cohort 1 1st week: 20mg 2nd week: 30mg 3rd week: 40mg 4th week: 50mg 5th week: 60mg Cohort 2*
1st week: 20mg 2nd week: 40mg 3rd week: 60mg Cohort 1b 1st - 2nd week: 10mg 3rd week: 20mg
4th week: 30mg 5th week: 40mg 6th week: 50mg 7th week: 60mg Cohort 3c* 1st week: 10mg 2nd
week: 15mg 3rd week: 20mg 4th week: 25mg 5th week: 30mg 6th week: 35mg 7th week: 40mg
*: The dose titration schedule of Cohort 2 and 3 may be altered based on Cohort 1 result.
Patients will be enrolled in Cohort 2 only when patients enrolled in Cohort 1 have safely
completed titration. Similary, patients will be enrolled in Cohort 3, only when patients
enrolled in Cohort 2 have safely completed titration.
Patients reaching their FID or having completed one week treatment with donepezil 40mg/day,
have two options.
Option 1: Patient will be allowed to immediately enter a long term extension at their Maximum
tolerated dose (MTD) or MAD.
Option 2: Patients may choose not to enter the long term extension, in which case the
Investigator will decide whether the patient should discontinue high dose of donepezil
without down-titration, or whether donepezil should be downtitrated to their own standard of
donepezil dose.
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