Alzheimer's Disease Clinical Trial
Official title:
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
This is an interventional, multi-national, multi-site, open-label extension study in patients
with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or
14862A (NCT02006641).
Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to
reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who
had completed the initial 28-week period (OLEX), were included in a 24 week open-label
treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of
concomitant memantine therapy in patients who were already on a stable treatment with
idalopirdine and donepezil and for whom memantine treatment was clinically indicated.
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