Clinical trial NCT01019421: Lu AE58054 Added to Donepezil for the Treatment for Moderate Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Cognition
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 278
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cognition after 24 weeks
timeFrame: Week 24
Secondary outcomes:
measure: Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics
timeFrame: Week 24
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: AU004
city: Heidelberg West
country: Australia
facility: AU002
city: Kew
country: Australia
facility: AU005
city: Nedlands
country: Australia
facility: AU001
city: Woodville South
country: Australia
facility: AU003
city: Toronto
country: Canada
facility: CA005
state: Ontario
city: Burlington
country: Canada
facility: CA007
city: Calgary
country: Canada
facility: CA006
city: Gatineau
country: Canada
facility: CA008
city: Kamloops
country: Canada
facility: CA011
city: Kingston
country: Canada
facility: CA002
city: Penticton
country: Canada
facility: CA010
city: Sherbrooke
country: Canada
facility: CA004
city: Toronto
country: Canada
facility: CA001
city: Kladno
country: Czech Republic
facility: CZ001
city: Kutna Hora
country: Czech Republic
facility: CZ002
city: Litomerice
country: Czech Republic
facility: CZ007
city: Praha 8
country: Czech Republic
facility: CZ004
city: Praha
country: Czech Republic
facility: CZ005
city: Praha
country: Czech Republic
facility: CZ008
city: Praha
country: Czech Republic
facility: CZ006
city: Rychnov nad Kneznou
country: Czech Republic
facility: CZ003
city: Ellwangen
country: Germany
facility: DE004
city: Erbach
country: Germany
facility: DE003
city: Frankfurt am Main
country: Germany
facility: DE005
city: Gunzburg
country: Germany
facility: DE002
city: Homburg
country: Germany
facility: DE001
city: Leipzig
country: Germany
facility: DE006
city: Munich
country: Germany
facility: DE009
city: Unterhaching
country: Germany
facility: DE007
city: Brescia
country: Italy
facility: IT001
city: Brescia
country: Italy
facility: IT005
city: Firenze
country: Italy
facility: IT008
city: Genova
country: Italy
facility: IT003
city: Lamezia Terme
country: Italy
facility: IT004
city: Milano
country: Italy
facility: IT007
city: Roma
country: Italy
facility: IT002
city: Bydgoszcz
country: Poland
facility: PL002
city: Krakow
country: Poland
facility: PL001
city: Lublin
country: Poland
facility: PL007
city: Sopot
country: Poland
facility: PL003
city: Szczecin
country: Poland
facility: PL009
city: Warszawa
country: Poland
facility: PL005
city: Warszaw
country: Poland
facility: PL004
city: Warszaw
country: Poland
facility: PL008
city: Barcelona
country: Spain
facility: ES002
city: Elche
country: Spain
facility: ES003
city: Madrid
country: Spain
facility: ES004
city: Madrid
country: Spain
facility: ES005
city: Majadahonda
country: Spain
facility: ES006
city: Terrassa
country: Spain
facility: ES001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.