Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

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:

- the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind,
placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

- The patient has completed Visit 6 (Week 28) of the OLEX.

- The patient, according to the judgement of the investigator, requires initiation of
treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

- The patient has a moderate or severe ongoing adverse event from the lead-in study
considered a potential safety risk by the investigator.

- The patient has experienced seizures before Completion Visit in the lead-in study.

- The patient has evidence of clinically significant disease.

- The patient's donepezil treatment is likely to be interrupted or discontinued during
the study.

- The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.