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

January 5, 2012 updated by: H. Lundbeck A/S

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Lu AE58054 in Patients With Moderate Alzheimer's Disease Treated With Donepezil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Gosford, Australia
        • AU004
      • Heidelberg West, Australia, 3081
        • AU002
      • Kew, Australia, 3101
        • AU005
      • Nedlands, Australia, 6009
        • AU001
      • Woodville South, Australia, 5011
        • AU003
  • Canada
      • Burlington, Canada, L7M 4Y1
        • CA007
      • Calgary, Canada, T2N 4Z6
        • CA006
      • Gatineau, Canada, JA 1K7
        • CA008
      • Kamloops, Canada, V2C 1K7
        • CA011
      • Kingston, Canada, K7L 5G2
        • CA002
      • Penticton, Canada, V2A 5C8
        • CA010
      • Sherbrooke, Canada, J1J 3H5
        • CA004
      • Toronto, Canada, M3B 2S7
        • CA001
    • Ontario
      • Toronto, Ontario, Canada
        • CA005
  • Czech Republic
      • Kladno, Czech Republic, 27301
        • CZ001
      • Kutna Hora, Czech Republic, 28401
        • CZ002
      • Litomerice, Czech Republic, 41201
        • CZ007
      • Praha, Czech Republic, 1000
        • CZ005
      • Praha, Czech Republic, 15800
        • CZ008
      • Praha, Czech Republic, 16000
        • CZ006
      • Praha 8, Czech Republic, 18000
        • CZ004
      • Rychnov nad Kneznou, Czech Republic, 516 01
        • CZ003
  • Germany
      • Ellwangen, Germany, 73479
        • DE004
      • Erbach, Germany, 64711
        • DE003
      • Frankfurt am Main, Germany, 60528
        • DE005
      • Gunzburg, Germany, 89312
        • DE002
      • Homburg, Germany, 66421
        • DE001
      • Leipzig, Germany, 4107
        • DE006
      • Munich, Germany, 81366
        • DE009
      • Unterhaching, Germany, 82008
        • DE007
  • Italy
      • Brescia, Italy, 25123
        • IT001
      • Brescia, Italy, 25127
        • IT005
      • Firenze, Italy, 50141
        • IT008
      • Genova, Italy
        • IT003
      • Lamezia Terme, Italy, 88046
        • IT004
      • Milano, Italy, 20122
        • IT007
      • Roma, Italy, 185
        • IT002
  • Poland
      • Bydgoszcz, Poland, 87-793
        • PL002
      • Krakow, Poland, 30-321
        • PL001
      • Lublin, Poland, 20-950
        • PL007
      • Sopot, Poland, 81-824
        • PL003
      • Szczecin, Poland, 70-215
        • PL009
      • Warszaw, Poland, 01-211
        • PL004
      • Warszaw, Poland, 02-765
        • PL008
      • Warszawa, Poland, 01-231
        • PL005
  • Spain
      • Barcelona, Spain, 8014
        • ES002
      • Elche, Spain, 3203
        • ES003
      • Madrid, Spain, 28040
        • ES005
      • Madrid, Spain, 28031
        • ES004
      • Majadahonda, Spain, 28222
        • ES006
      • Terrassa, Spain, 8221
        • ES001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Add-on treatment to donepezil
EXPERIMENTAL: Lu AE58054
Drug: Lu AE58054
Add-on treatment to donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognition after 24 weeks
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in global function, activities of daily living, safety and tolerability, pharmacokinetics/pharmacodynamics
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12936A
  • EudraCT 2009-011845-24 (REGISTRY: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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