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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01019421
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Lu AE58054 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2009
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arm Intervention/treatment
Experimental: Lu AE58054 Drug: Lu AE58054
Add-on treatment to donepezil

Placebo Comparator: Placebo Drug: Placebo
Add-on treatment to donepezil

Primary Outcome Measures :
  1. Change in cognition after 24 weeks [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics [ Time Frame: Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019421

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Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01019421    
Other Study ID Numbers: 12936A
EudraCT 2009-011845-24 ( Registry Identifier: EudraCT )
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012
Keywords provided by H. Lundbeck A/S:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders