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

• Status: Completed
• Trial end date: 2017-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Donepezil; Memantine

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.