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
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.
Inclusion Criteria:
For patients in the OLEX-MEM:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Qubec, Canada
Praha 10 - Strasnice, Czechia