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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019421
• Other study ID #: 12936A
• Secondary ID: EudraCT 2009-011
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2009
• Last updated: January 5, 2012
• Start date: December 2009

Study information

• Verified date: January 2012
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 278
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Australia	AU004	East Gosford
Australia	AU002	Heidelberg West
Australia	AU005	Kew
Australia	AU001	Nedlands
Australia	AU003	Woodville South
Canada	CA007	Burlington
Canada	CA006	Calgary
Canada	CA008	Gatineau
Canada	CA011	Kamloops
Canada	CA002	Kingston
Canada	CA010	Penticton
Canada	CA004	Sherbrooke
Canada	CA001	Toronto
Canada	CA005	Toronto	Ontario
Czech Republic	CZ001	Kladno
Czech Republic	CZ002	Kutna Hora
Czech Republic	CZ007	Litomerice
Czech Republic	CZ005	Praha
Czech Republic	CZ006	Praha
Czech Republic	CZ008	Praha
Czech Republic	CZ004	Praha 8
Czech Republic	CZ003	Rychnov nad Kneznou
Germany	DE004	Ellwangen
Germany	DE003	Erbach
Germany	DE005	Frankfurt am Main
Germany	DE002	Gunzburg
Germany	DE001	Homburg
Germany	DE006	Leipzig
Germany	DE009	Munich
Germany	DE007	Unterhaching
Italy	IT001	Brescia
Italy	IT005	Brescia
Italy	IT008	Firenze
Italy	IT003	Genova
Italy	IT004	Lamezia Terme
Italy	IT007	Milano
Italy	IT002	Roma
Poland	PL002	Bydgoszcz
Poland	PL001	Krakow
Poland	PL007	Lublin
Poland	PL003	Sopot
Poland	PL009	Szczecin
Poland	PL004	Warszaw
Poland	PL008	Warszaw
Poland	PL005	Warszawa
Spain	ES002	Barcelona
Spain	ES003	Elche
Spain	ES004	Madrid
Spain	ES005	Madrid
Spain	ES006	Majadahonda
Spain	ES001	Terrassa

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition after 24 weeks		Week 24	No
Secondary	Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics		Week 24	Yes