Study of Lu AE58054 in patients with mild-moderate Alzheimer's disease treated with an acetylcholinesterase inhibitor
- Conditions
- Alzheimer´s diseaseMedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-004765-40-DE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
• 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 an AChEI.
• 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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 612
• 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 current AChEI 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 Main Objective: To establish the efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer’s disease (AD);Secondary Objective: • To investigate the effect of Lu AE58054 as adjunctive therapy to AChEIs on neuropsychiatric symptoms in patients with mild-moderate AD<br>• To evaluate the safety and tolerability of Lu AE58054 as adjunctive therapy to AChEIs in patients with mild-moderate AD<br>;Primary end point(s): Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score;Timepoint(s) of evaluation of this end point: Baseline and Week 24
- Secondary Outcome Measures
Name Time Method