Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease (STAR Extension)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Idalopirdine (Lu AE58054) 60 mg
Idalopirdine 60 mg + memantine
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.