European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Bellus Health Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00217763
First received: September 14, 2005
Last updated: December 7, 2007
Last verified: December 2007
  Purpose

The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: 3APS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Bellus Health Inc:

Estimated Enrollment: 930
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
Detailed Description:
  • Duration of treatment: 18 months
  • 3 treatment arms:

Placebo and 2 different doses of active drug.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.

INCLUSION CRITERIA:

Participants must meet the following inclusion criteria to be eligible.

  • Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
  • 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:

Patients will not be eligible to participate in the study if they meet any of the following 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217763

  Hide Study Locations
Locations
Belgium
Middelheim Ziekenhuis Lindendreef
Antwerp, Belgium
University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD
Edegem, Belgium, 2650
Memory Clinic University Hospital Gasthuisberg, Neurology Department
Leuven, Belgium, 3000
Memory Centre, Polycliniques Brull, CHU de Liège
Liege, Belgium
France
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, 34000
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
Germany
Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie
Berlin, Germany
Gemeinschaftspraxis
Bochum (Langendreer), 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
Arzneimittelforschung Leipzig GmbH
Leipzig, Germany
Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg
Mannheim, Germany
Munich, Germany
Italy
IRCCS Centro San Giovanni di Dio- Fatebenefratelli
Brescia, Italy
San Martino Hospital - Padiglione Specialita' Fondi
Genova, Italy, 16132
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
Netherlands
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
Poland
Bydgoszcz, Poland
Krakow, Poland
Lodz, Poland
Sopot, Poland
Warsaw, Poland
Wroclaw, Poland
Spain
Baracaldo, Spain
Hospital del Mar- Servicio de Neurologia
Barcelona, Spain
Fundaciò ACE- Institut Català de Neurociències Aplicades
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 Universitario Ramón y Cajal - Unidad de Geriatria
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitairo La Paz
Madrid, Spain
Pamplona, Spain
Sweden
Linkoping, Sweden
Lund, Sweden
Neuropsychiatric Clinic - University Hospital MAS
Malmo, Sweden, 20502
Mölndal, Sweden
Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge
Stockholm, Sweden, 141 86
Memory clinic - Uddevalla Hospital
Uddevalla, Sweden
Memory Clinic -Geriatric Centre - Academic Hospital
Uppsala, Sweden
Switzerland
Memory Clinic - Neuropsychology Center - University Hospital
Basel, Switzerland
Geneva, Switzerland
United Kingdom
Research Institute for Care of Elderly - St Martin's Hospital
Bath, United Kingdom
Memory Assessment Centre
Blackpool, United Kingdom
Fylde Medical Clinic
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
Sponsors and Collaborators
Bellus Health Inc
Investigators
Principal Investigator: Pr. Bruno Vellas University Hospital Center, Toulouse
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00217763     History of Changes
Other Study ID Numbers: CL-758010
Study First Received: September 14, 2005
Last Updated: December 7, 2007
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Spain: Spanish Agency of Medicines
Italy: Ministry of Health
Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic

Keywords provided by Bellus Health Inc:
Dementia
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Homotaurine
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014