NCT02006654

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 734 (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 acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-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 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).

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: 2014-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-12-10
• Last updated: 2018-02-07
• Results posted: 2018-02-07

Locations

107 sites across 15 countries: United States, Australia, Brazil, Czechia, Germany, Israel, Mexico, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom