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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01019421
First received: November 24, 2009
Last updated: January 5, 2012
Last verified: January 2012

November 24, 2009
January 5, 2012
December 2009
December 2011   (final data collection date for primary outcome measure)
Change in cognition after 24 weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019421 on ClinicalTrials.gov Archive Site
Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Lu AE58054
    Add-on treatment to donepezil
  • Drug: Placebo
    Add-on treatment to donepezil
  • Experimental: Lu AE58054
    Intervention: Drug: Lu AE58054
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Germany,   Italy,   Poland,   Spain
 
NCT01019421
12936A, EudraCT 2009-011845-24
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP