NCT01955161

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 933 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

Detailed description

The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 30 mg/day or 60 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Once daily, matching placebo capsules, orally
DRUG	Idalopirdine	Once daily, encapsulated tablets, orally

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-10-07
• Last updated: 2017-09-19
• Results posted: 2017-09-19

Locations

137 sites across 16 countries: United States, Argentina, Belgium, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Italy, Poland, Romania, South Africa, Spain, Ukraine