NCT02079246

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,463 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Idalopirdine 60 mg	once daily, encapsulated tablets, orally

Timeline

• Start date: 2014-04-07
• Primary completion: 2017-07-06
• Completion: 2017-07-06
• First posted: 2014-03-05
• Last updated: 2018-08-10
• Results posted: 2018-08-10

Locations

258 sites across 27 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom