Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: November 24, 2009
Last updated: January 5, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Alzheimer's Disease
Drug: Lu AE58054
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change in cognition after 24 weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 278
Study Start Date: December 2009
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AE58054 Drug: Lu AE58054
Add-on treatment to donepezil
Placebo Comparator: Placebo Drug: Placebo
Add-on treatment to donepezil

Detailed Description:
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.

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01019421

  Show 51 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S Identifier: NCT01019421     History of Changes
Other Study ID Numbers: 12936A  EudraCT 2009-011845-24 
Study First Received: November 24, 2009
Last Updated: January 5, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines

Keywords provided by H. Lundbeck A/S:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Physiological Effects of Drugs processed this record on May 23, 2016