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

December 7, 2007 updated by: Bellus Health Inc

A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Duration of treatment: 18 months
  • 3 treatment arms:

Placebo and 2 different doses of active drug.

Study Type

Interventional

Enrollment (Anticipated)

930

Phase

  • Phase 3

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

  • Belgium
      • Antwerp, Belgium
        • Middelheim Ziekenhuis Lindendreef
      • Edegem, Belgium, 2650
        • University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD
      • Leuven, Belgium, 3000
        • Memory Clinic University Hospital Gasthuisberg, Neurology Department
      • Liege, Belgium
        • Memory Centre, Polycliniques Brull, CHU de Liège
  • France
      • Besançon, France
      • Bordeaux, France
        • Hôpital Pellegrin CHU de Bordeaux
      • Dijon, France
      • Lille, France
        • Centre Hospitalier Regional Universitaire de Lille
      • Marseille, France
        • Hôpital Sainte Marguerite Service de neuro-geriatrie
      • Montpellier, France, 34000
        • Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon
      • Nice, France
        • Centre Mémoire de Ressources et de Recherche Hôpital Pasteur
      • Paris, France
        • Hôpital Broca
      • Reims, France
        • CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique
      • Rennes, France
        • Hôpital Hôtel Dieu - Consultation de Gérontologie
      • Toulouse, France
        • CHU Purpan
      • Tours, France
  • Germany
      • Berlin, Germany
        • Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie
      • Bochum (Langendreer), Germany
        • Gemeinschaftspraxis
      • Frankfurt, Germany
        • Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie
      • Hamburg, Germany
        • Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy
      • Heidelberg, Germany
        • Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz
      • Leipzig, Germany
        • Arzneimittelforschung Leipzig GmbH
      • Mannheim, Germany
        • Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg
      • Munich, Germany
  • Italy
      • Brescia, Italy
        • IRCCS Centro San Giovanni di Dio- Fatebenefratelli
      • Genova, Italy, 16132
        • San Martino Hospital - Padiglione Specialita' Fondi
      • Modena, Italy
        • Dept. of Neurosciences TCR - University of Modena and Reggio Emilia
      • Perugia, Italy
      • Pisa, Italy
        • Department of Neuroscience - Section of Neurology - University of Pisa
      • Rome, Italy
      • Rome, Italy
        • Universita' Cattolica del Sacro Cuore
      • Vicenza, Italy
  • Netherlands
      • Alkmaar, Netherlands
        • Medisch Centrum Alkmaar
      • Amsterdam, Netherlands
        • Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center
      • Blaricum, Netherlands
      • Nijmegen, Netherlands
        • Memory Clinic UMC St Radboud - Alzheimer Centre
  • Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Sopot, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Spain
      • Baracaldo, Spain
      • Barcelona, 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
      • Girona, Spain
        • Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitairo La Paz
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal - Unidad de Geriatria
      • Pamplona, Spain
  • Sweden
      • Linkoping, Sweden
      • Lund, Sweden
      • Malmo, Sweden, 20502
        • Neuropsychiatric Clinic - University Hospital MAS
      • Mölndal, Sweden
      • Stockholm, Sweden, 141 86
        • Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge
      • Uddevalla, Sweden
        • Memory clinic - Uddevalla Hospital
      • Uppsala, Sweden
        • Memory Clinic -Geriatric Centre - Academic Hospital
  • Switzerland
      • Basel, Switzerland
        • Memory Clinic - Neuropsychology Center - University Hospital
      • Geneva, Switzerland
  • United Kingdom
      • Bath, United Kingdom
        • Research Institute for Care of Elderly - St Martin's Hospital
      • Blackpool, United Kingdom
        • Fylde Medical Clinic
      • Blackpool, United Kingdom
        • Memory Assessment Centre
      • Cardiff, United Kingdom
        • Wales College of Medicine - Llandough Hospital
      • East Sussex, United Kingdom
      • Glasgow, United Kingdom
        • Glasgow Memory Clinic - Golden Jubilee National Hospital
      • Perth, United Kingdom
        • Murray Royal Hospital
      • Southampton, United Kingdom
        • Memory Assessment Centre - Moorgreen Hospital
      • Swindon, United Kingdom
        • Kingshill Research Centre - Victoria Hospital

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

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.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Bellus Health Inc

Investigators

  • Principal Investigator: Pr. Bruno Vellas, University Hospital Center, Toulouse

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.

Helpful Links

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

September 1, 2005

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-758010

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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