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

NCT ID: NCT01019421

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AE58054

Group Type: EXPERIMENTAL

Lu AE58054

Intervention Type: DRUG

Add-on treatment to donepezil

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Add-on treatment to donepezil

Interventions

Lu AE58054

Add-on treatment to donepezil

Intervention Type: DRUG

Placebo

Add-on treatment to donepezil

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

AU004

East Gosford, , Australia

AU002

Heidelberg West, , Australia

AU005

Kew, , Australia

AU001

Nedlands, , Australia

AU003

Woodville South, , Australia

CA005

Toronto, Ontario, 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

CZ001

Kladno, , Czechia

CZ002

Kutná Hora, , Czechia

CZ007

Litoměřice, , Czechia

CZ005

Prague, , Czechia

CZ008

Prague, , Czechia

CZ006

Prague, , Czechia

CZ004

Prague, , Czechia

CZ003

Rychnov nad Kněžnou, , Czechia

DE004

Ellwangen, , Germany

DE003

Erbach im Odenwald, , Germany

DE005

Frankfurt am Main, , Germany

DE002

Günzburg, , Germany

DE001

Homburg, , Germany

DE006

Leipzig, , Germany

DE009

Munich, , Germany

DE007

Unterhaching, , Germany

IT001

Brescia, , Italy

IT005

Brescia, , Italy

IT008

Florence, , Italy

IT003

Genova, , Italy

IT004

Lamezia Terme, , Italy

IT007

Milan, , Italy

IT002

Roma, , Italy

PL002

Bydgoszcz, , Poland

PL001

Krakow, , Poland

PL007

Lublin, , Poland

PL003

Sopot, , Poland

PL009

Szczecin, , Poland

PL004

Warsaw, , Poland

PL005

Warsaw, , Poland

PL008

Warsaw, , Poland

ES002

Barcelona, , Spain

ES003

Elche, , Spain

ES004

Madrid, , Spain

ES005

Madrid, , Spain

ES006

Majadahonda, , Spain

ES001

Terrassa, , Spain

Countries

Australia; Canada; Czechia; Germany; Italy; Poland; Spain

References

Wilkinson D, Windfeld K, Colding-Jorgensen E. Safety and efficacy of idalopirdine, a 5-HT6 receptor antagonist, in patients with moderate Alzheimer's disease (LADDER): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2014 Nov;13(11):1092-1099. doi: 10.1016/S1474-4422(14)70198-X. Epub 2014 Oct 5.

Reference Type: DERIVED

PMID: 25297016 (View on PubMed)

Other Identifiers

EudraCT 2009-011845-24

Identifier Type: REGISTRY

Identifier Source: secondary_id

12936A

Identifier Type: -

Identifier Source: org_study_id