Study of Lu AE58054 in Patients with Mild-moderate Alzheimer's disease treated with Donepezil

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 840

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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 714

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

Related Trials

Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo in the treatment of depression in patients with Bipolar I or II Disorder

H. Lundbeck a/s

Updated 10/21/2013

Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo in the treatment of depression in patients with Bipolar I or II Disorder

H. Lundbeck a/s

Updated 3/19/2012

Randomised, double-blind, parallel-group, placebo-controlled, duloxetine referenced, dose-finding study of Lu AA24530 in Major Depressive Disorder

H. Lundbeck a/s

Updated 5/1/2012

Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo in the treatment of depression in patients with Bipolar I or II Disorder

Phase 1

H. Lundbeck a/s

Updated 8/8/2022

Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo in the treatment of depression in patients with Bipolar I or II Disorder

H. Lundbeck a/s

Updated 3/19/2012

A study measuring the effect and safety of 10 or 20 mg/day of the study drug Lu AA21004 and placebo in the treatment of cognitive dysfunction (such as problems with the ability to think, learn and remember, plan, solve problems and concentrate) in adult patients with Major Depressive Disorder. Patients will be assigned to treatment based on computer-aided random draw and no one involved in the study will know what treatment is given until the whole study is finished

H. Lundbeck A/S

Updated 8/19/2013