Study of Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 930

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 790

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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