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

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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).


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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Atlanta, Georgia 30322
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Albany, New York
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Amherst, New York 14226
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Buenos Aires,
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Chicago, Illinois 60612
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Columbus, Ohio 43221
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Edmond, Oklahoma
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41 Flowood Drive
Flowood, Mississippi 39232
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Freeport, Maine 04032
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Indianapolis, Indiana 46202
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Kalamazoo, Michigan 49048
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Manhasset, New York 11030
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Port Charlotte, Florida 33980
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Santa Ana, California 92705
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