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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

Description

Phase

Phase 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.

Sites

  • California

    • US018, Santa Ana, California, 92705
    • US023, Imperial, California, 92251

  • Arizona

    • US012, Phoenix, Arizona, 85006

  • Arkansas

    • US024, Little Rock, Arkansas, 72205

  • Mississippi

    • US041, Flowood, Mississippi, 39232

  • Wisconsin

    • US025, Madison, Wisconsin, 53705
    • US004, Milwaukee, Wisconsin, 53226

  • Illinois

    • US030, Chicago, Illinois, 60612

  • Alabama

    • US027, Birmingham, Alabama, 35294

  • Indiana

    • US040, Indianapolis, Indiana, 46202

  • Michigan

    • US035, Kalamazoo, Michigan, 49048

  • Ohio

    • US007, Centerville, Ohio, 45459

  • Georgia

    • US020, Atlanta, Georgia, 30322

  • Italy

    • IT002, Firenze, 50139

  • Czech Republic

    • CZ004, Pardubice, 53203

  • Germany

    • DE005, Hannover, 30559
Presentado por SC CTSI