Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 6/1/2017 |
Start Date: | October 2013 |
End Date: | July 2016 |
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
To establish efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic
treatment of patients with mild-to-moderate Alzheimer's disease (AD).
treatment of patients with mild-to-moderate Alzheimer's disease (AD).
Inclusion Criteria:
- The patient has a knowledgeable and reliable caregiver.
- The patient is an outpatient.
- The patient has probable AD.
- The patient has mild to moderate AD.
- Stable treatment with donepezil.
- The patient, if a woman, must have had her last natural menstruation ≥24 months prior
to baseline, OR be surgically sterile.
- The patient, if a man, agrees to protocol-defined use of effective contraception if
his female partner is of childbearing potential, OR must have been surgically
sterilised prior to the screening visit.
Exclusion Criteria:
- The patient has evidence of any clinically significant neurodegenerative disease, or
other serious neurological disorders other than AD.
- The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
Text Revision (DSM-IV-TR) Axis I disorder other than AD.
- The patient has evidence of clinically significant disease.
- The patient's donepezil therapy is likely to be interrupted or discontinued during
the study.
- The patient is currently receiving memantine or has taken memantine within 2 months
prior to screening.
Other inclusion and exclusion criteria may apply.
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