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

NCT01019421 | Completed Phase 2

• 2 other identifiers: 12936AEudraCT 2009-011845-24
• Study Type: interventional
• Target: 278
• Locations: 7 countries
• Sites: 51

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.

Conditions

Alzheimer's Disease

Keywords

Cognition

Outcome Measures

Primary Outcomes (1)

• Change in cognition after 24 weeks

  Week 24

Secondary Outcomes (1)

• Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics

  Week 24

Study Arms (2)

Lu AE58054

EXPERIMENTAL

Drug: Lu AE58054

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lu AE58054 DRUG

Add-on treatment to donepezil

Lu AE58054

Placebo DRUG

Add-on treatment to donepezil

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (51)

AU004

East Gosford, Australia

Location

AU002

Heidelberg West, 3081, Australia

Location

AU005

Kew, 3101, Australia

Location

AU001

Nedlands, 6009, Australia

Location

AU003

Woodville South, 5011, Australia

Location

CA005

Toronto, Ontario, Canada

Location

CA007

Burlington, L7M 4Y1, Canada

Location

CA006

Calgary, T2N 4Z6, Canada

Location

CA008

Gatineau, JA 1K7, Canada

Location

CA011

Kamloops, V2C 1K7, Canada

Location

CA002

Kingston, K7L 5G2, Canada

Location

CA010

Penticton, V2A 5C8, Canada

Location

CA004

Sherbrooke, J1J 3H5, Canada

Location

CA001

Toronto, M3B 2S7, Canada

Location

CZ001

Kladno, 27301, Czechia

Location

CZ002

Kutná Hora, 28401, Czechia

Location

CZ007

Litoměřice, 41201, Czechia

Location

CZ005

Prague, 1000, Czechia

Location

CZ008

Prague, 15800, Czechia

Location

CZ006

Prague, 16000, Czechia

Location

CZ004

Prague, 18000, Czechia

Location

CZ003

Rychnov nad Kněžnou, 516 01, Czechia

Location

DE004

Ellwangen, 73479, Germany

Location

DE003

Erbach im Odenwald, 64711, Germany

Location

DE005

Frankfurt am Main, 60528, Germany

Location

DE002

Günzburg, 89312, Germany

Location

DE001

Homburg, 66421, Germany

Location

DE006

Leipzig, 4107, Germany

Location

DE009

Munich, 81366, Germany

Location

DE007

Unterhaching, 82008, Germany

Location

IT001

Brescia, 25123, Italy

Location

IT005

Brescia, 25127, Italy

Location

IT008

Florence, 50141, Italy

Location

IT003

Genova, Italy

Location

IT004

Lamezia Terme, 88046, Italy

Location

IT007

Milan, 20122, Italy

Location

IT002

Roma, 185, Italy

Location

PL002

Bydgoszcz, 87-793, Poland

Location

PL001

Krakow, 30-321, Poland

Location

PL007

Lublin, 20-950, Poland

Location

PL003

Sopot, 81-824, Poland

Location

PL009

Szczecin, 70-215, Poland

Location

PL004

Warsaw, 01-211, Poland

Location

PL005

Warsaw, 01-231, Poland

Location

PL008

Warsaw, 02-765, Poland

Location

ES002

Barcelona, 8014, Spain

Location

ES003

Elche, 3203, Spain

Location

ES004

Madrid, 28031, Spain

Location

ES005

Madrid, 28040, Spain

Location

ES006

Majadahonda, 28222, Spain

Location

ES001

Terrassa, 8221, Spain

Location

Related Publications (1)

• 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.

  PMID: 25297016 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

CA (9); ES (6); AU (5); DE (8); IT (7); PL (8); CZ (8)