Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease
- Registration Number
- NCT01019421
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lu AE58054 Lu AE58054 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in cognition after 24 weeks Week 24
- Secondary Outcome Measures
Name Time Method Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics Week 24
Trial Locations
- Locations (51)
CZ001
🇨🇿Kladno, Czech Republic
CZ005
🇨🇿Praha, Czech Republic
CZ006
🇨🇿Praha, Czech Republic
CA001
🇨🇦Toronto, Canada
CA010
🇨🇦Penticton, Canada
AU004
🇦🇺East Gosford, Australia
AU002
🇦🇺Heidelberg West, Australia
CA005
🇨🇦Toronto, Ontario, Canada
CZ002
🇨🇿Kutna Hora, Czech Republic
DE007
🇩🇪Unterhaching, Germany
PL002
🇵🇱Bydgoszcz, Poland
PL001
🇵🇱Krakow, Poland
IT005
🇮🇹Brescia, Italy
DE009
🇩🇪Munich, Germany
IT001
🇮🇹Brescia, Italy
IT002
🇮🇹Roma, Italy
IT008
🇮🇹Firenze, Italy
IT004
🇮🇹Lamezia Terme, Italy
IT003
🇮🇹Genova, Italy
IT007
🇮🇹Milano, Italy
ES006
🇪🇸Majadahonda, Spain
AU001
🇦🇺Nedlands, Australia
CA011
🇨🇦Kamloops, Canada
CA004
🇨🇦Sherbrooke, Canada
CZ007
🇨🇿Litomerice, Czech Republic
CZ004
🇨🇿Praha 8, Czech Republic
DE005
🇩🇪Frankfurt am Main, Germany
CZ008
🇨🇿Praha, Czech Republic
CZ003
🇨🇿Rychnov nad Kneznou, Czech Republic
DE004
🇩🇪Ellwangen, Germany
DE003
🇩🇪Erbach, Germany
DE002
🇩🇪Gunzburg, Germany
DE001
🇩🇪Homburg, Germany
PL004
🇵🇱Warszaw, Poland
PL007
🇵🇱Lublin, Poland
PL003
🇵🇱Sopot, Poland
PL005
🇵🇱Warszawa, Poland
PL009
🇵🇱Szczecin, Poland
ES003
🇪🇸Elche, Spain
ES005
🇪🇸Madrid, Spain
ES002
🇪🇸Barcelona, Spain
PL008
🇵🇱Warszaw, Poland
ES001
🇪🇸Terrassa, Spain
ES004
🇪🇸Madrid, Spain
CA008
🇨🇦Gatineau, Canada
DE006
🇩🇪Leipzig, Germany
AU005
🇦🇺Kew, Australia
CA007
🇨🇦Burlington, Canada
AU003
🇦🇺Woodville South, Australia
CA006
🇨🇦Calgary, Canada
CA002
🇨🇦Kingston, Canada