This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
CPC1
West Palm Beach, Florida, United States
Donepezil Maximum Tolerated Dose (MTD)
Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
Time frame: 6 months
Number of Subjects With Any TEAEs
Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study.
Time frame: 6 months
Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.
Time frame: Day 1 (baseline) to end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.