Trials / Completed
CompletedNCT01019421
Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 278 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in treatment with donepezil.
Detailed description
Multi-centre, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 as add-on to donepezil. The patient has probable Alzheimer's Disease consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AE58054 | Add-on treatment to donepezil |
| DRUG | Placebo | Add-on treatment to donepezil |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-12-01
- First posted
- 2009-11-25
- Last updated
- 2012-01-06
Locations
51 sites across 7 countries: Australia, Canada, Czechia, Germany, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT01019421. Inclusion in this directory is not an endorsement.