Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion 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.
- 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.
- US018, Santa Ana, California, 92705
- US023, Imperial, California, 92251
- US012, Phoenix, Arizona, 85006
- US024, Little Rock, Arkansas, 72205
- US041, Flowood, Mississippi, 39232
- US025, Madison, Wisconsin, 53705
- US004, Milwaukee, Wisconsin, 53226
- US030, Chicago, Illinois, 60612
- US027, Birmingham, Alabama, 35294
- US040, Indianapolis, Indiana, 46202
- US035, Kalamazoo, Michigan, 49048
- US007, Centerville, Ohio, 45459
- US020, Atlanta, Georgia, 30322
- IT002, Firenze, 50139
- CZ004, Pardubice, 53203
- DE005, Hannover, 30559