European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
NCT ID: NCT00217763
Last Updated: 2007-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
930 participants
INTERVENTIONAL
2005-09-30
2007-12-31
Brief Summary
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Detailed Description
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* 3 treatment arms:
Placebo and 2 different doses of active drug.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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3APS
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
* Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
* Potential participant must be treated with an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
* Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
* Fluency (oral and written) in the language in which the standardized tests will be administered.
* Signed informed consent from potential participant or legal representative and caregiver.
Exclusion Criteria
* Potential participant with any other cause of dementia.
* Life expectancy less than 2 years.
* Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
* Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
* Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
* Previous exposure to 3APS.
* Inability to swallow pills.
50 Years
ALL
No
Sponsors
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Bellus Health Inc. - a GSK company
INDUSTRY
Principal Investigators
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Pr. Bruno Vellas
Role: PRINCIPAL_INVESTIGATOR
University Hospital Center, Toulouse
Locations
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Middelheim Ziekenhuis Lindendreef
Antwerp, , Belgium
University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD
Edegem, , Belgium
Memory Clinic University Hospital Gasthuisberg, Neurology Department
Leuven, , Belgium
Memory Centre, Polycliniques Brull, CHU de Liège
Liège, , Belgium
Besançon, , France
Hôpital Pellegrin CHU de Bordeaux
Bordeaux, , France
Dijon, , France
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
Hôpital Sainte Marguerite Service de neuro-geriatrie
Marseille, , France
Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon
Montpellier, , France
Centre Mémoire de Ressources et de Recherche Hôpital Pasteur
Nice, , France
Hôpital BROCA
Paris, , France
CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique
Reims, , France
Hôpital Hôtel Dieu - Consultation de Gérontologie
Rennes, , France
CHU Purpan
Toulouse, , France
Tours, , France
Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie
Berlin, , Germany
Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie
Frankfurt, , Germany
Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy
Hamburg, , Germany
Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz
Heidelberg, , Germany
Gemeinschaftspraxis
Langendreer, , Germany
Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg
Mannheim, , Germany
Munich, , Germany
IRCCS Centro San Giovanni di Dio- Fatebenefratelli
Brescia, , Italy
San Martino Hospital - Padiglione Specialita' Fondi
Genova, , Italy
Dept. of Neurosciences TCR - University of Modena and Reggio Emilia
Modena, , Italy
Perugia, , Italy
Department of Neuroscience - Section of Neurology - University of Pisa
Pisa, , Italy
Universita' Cattolica del Sacro Cuore
Rome, , Italy
Rome, , Italy
Vicenza, , Italy
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center
Amsterdam, , Netherlands
Blaricum, , Netherlands
Memory Clinic UMC St Radboud - Alzheimer Centre
Nijmegen, , Netherlands
Bydgoszcz, , Poland
Krakow, , Poland
Lodz, , Poland
Sopot, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barakaldo, , Spain
Fundaciò ACE- Institut Català de Neurociències Aplicades
Barcelona, , Spain
Hospital del Mar- Servicio de Neurologia
Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Servicio de Neurología, Unitad de Memoria
Barcelona, , Spain
Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària
Girona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitairo La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal - Unidad de Geriatria
Madrid, , Spain
Pamplona, , Spain
Linköping, , Sweden
Lund, , Sweden
Neuropsychiatric Clinic - University Hospital MAS
Malmo, , Sweden
Mölndal, , Sweden
Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge
Stockholm, , Sweden
Memory clinic - Uddevalla Hospital
Uddevalla, , Sweden
Memory Clinic -Geriatric Centre - Academic Hospital
Uppsala, , Sweden
Memory Clinic - Neuropsychology Center - University Hospital
Basel, , Switzerland
Geneva, , Switzerland
Research Institute for Care of Elderly - St Martin's Hospital
Bath, , United Kingdom
Fylde Medical Clinic
Blackpool, , United Kingdom
Memory Assessment Centre
Blackpool, , United Kingdom
Wales College of Medicine - Llandough Hospital
Cardiff, , United Kingdom
East Sussex, , United Kingdom
Glasgow Memory Clinic - Golden Jubilee National Hospital
Glasgow, , United Kingdom
Murray Royal Hospital
Perth, , United Kingdom
Memory Assessment Centre - Moorgreen Hospital
Southampton, , United Kingdom
Kingshill Research Centre - Victoria Hospital
Swindon, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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CL-758010
Identifier Type: -
Identifier Source: org_study_id