Trials / Completed
CompletedNCT02006641
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
- 858 (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 10 mg/day or 30 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Once daily, matching placebo capsules, orally |
| DRUG | Idalopirdine | Once daily, encapsulated tablets, orally |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2013-12-10
- Last updated
- 2018-02-20
- Results posted
- 2018-02-20
Locations
162 sites across 19 countries: United States, Argentina, Brazil, Canada, Croatia, Czechia, Estonia, Finland, France, Hungary, Ireland, Israel, Italy, Lithuania, Poland, Portugal, South Korea, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02006641. Inclusion in this directory is not an endorsement.