Official Title: “Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil”

The purpose of this study is to accept or reject the hypothesis that Lu AE58054 improves cognition and functional outcomes in patients with moderate Alzheimer's Disease, already in treatment with donepezil.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2011

Multi-centre, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 as add-on to donepezil. The patient has probable Alzheimer's Disease consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.

Intervention(s) in this Clinical Trial

• Drug: Lu AE58054
  • Add-on treatment to donepezil
• Drug: Placebo
  • Add-on treatment to donepezil

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lu AE58054
• Placebo Comparator: Placebo

Primary Measures

• Change in cognition after 24 weeks
  • Time Frame: Week 24
    Safety Issue?: No

Secondary Measures

• Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics
  • Time Frame: Week 24
    Safety Issue?: Yes

Inclusion Criteria:

• The patient (or if applicable the legally acceptable representative (LAR) and if different from the responsible caregiver) and the responsible caregiver are able to read and understand the Informed Consent Form.
• The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
• The patient (or if applicable the LAR and if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form.
• The patient has probable AD consistent with NINCDS-ADRDA criteria.
• The patient is a man or woman, aged at least 50 years.
• The patient has been treated with donepezil on a stable dose for at least 3 months prior to screening.

Exclusion Criteria:

• The patient has evidence of any clinically significant neurodegenerative disease or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma and, primary or secondary cerebral neoplasia.
• The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD including amnestic disorders, major depressive disorder, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, psychosis, panic, post traumatic stress disorder or/and cognitive disorder not otherwise specified.
• The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association
• Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia.
• The patient has CT or MRI evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection or any clinically significant central nervous system disease other than AD.
• The patient has clinically significant abnormal vital signs.
• The patient has one or more laboratory values outside the normal range, based on the blood or urine samples, which are, in the investigator's judgement, considered to be clinically significant.
• The patient has a clinically significant abnormal ECG.
• The patient has an oncological diagnosis (haematological or solid tumour) that is currently being treated, or for which there has been treatment within 5 years preceding screening, or for which there is still evidence of active disease (patients with local dermatological tumours such as basal or squamous cell carcinoma may be included).
• The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
• The patient has a disease or takes medication that, in the investigator's judgement, could interfere with the assessments of safety, tolerability, or efficacy.
• The patient is, in the investigator's judgement, unlikely to comply with the clinical study protocol or is unsuitable for any reason.
• The patient is a member of the site personnel or their immediate families.
• The patient is treated against his/her will (for example, by court order).
• The patient or patient caregiver is unwilling or unable to abide by the visit schedule and other requirements of the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: H. Lundbeck A/S

Overall Clinical Trial Officials and Contacts

Email contact via H. Lundbeck A/S Study Director LundbeckClinicalTrials@lundbeck.com  

Overall Contact: Email contact via H. Lundbeck A/S  LundbeckClinicalTrials@lundbeck.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019421

Study ID Number: 12936A

ClinicalTrials.gov Identifier: NCT01019421

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration