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

Last updated: December 7, 2007
Sponsor: Bellus Health Inc
Overall Status: Trial Status Unknown

Phase

3

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00217763
CL-758010
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofNeurological and Communicative Disorders and Stroke/Alzheimer's Disease and RelatedDisorders Association (NINCDS-ADRDA criteria).

  • Severity of dementia of mild to moderate degree as assessed by the Mini Mental StateExamination (MMSE) performed at the screening visit.

  • Patient must be living in the community with a reliable caregiver. Participant livingin an assisted living facility may be included if study medication intake issupervised 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 4months prior to the screening visit and during the entire study period.

  • Participants must not have taken memantine for at least 4 months prior to thecommencement of screening. The use of memantine is prohibited during the course of thestudy.

  • Fluency (oral and written) in the language in which the standardized tests will beadministered.

  • Signed informed consent from potential participant or legal representative andcaregiver.

Exclusion

EXCLUSION CRITERIA: Patients will not be eligible to participate in the study if they meet any of the followingcriteria:

  • Potential participant with any other cause of dementia.

  • Life expectancy less than 2 years.

  • Potential participant with a clinically significant and/or uncontrolled condition orother 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 duringthe entire study.

  • Previous exposure to 3APS.

  • Inability to swallow pills.

Study Design

Total Participants: 930
Study Start date:
September 01, 2005
Estimated Completion Date:
December 31, 2007

Study Description

  • Duration of treatment: 18 months

  • 3 treatment arms:

Placebo and 2 different doses of active drug.

Connect with a study center

  • Middelheim Ziekenhuis Lindendreef

    Antwerp,
    Belgium

    Site Not Available

  • University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD

    Edegem, 2650
    Belgium

    Site Not Available

  • Memory Clinic University Hospital Gasthuisberg, Neurology Department

    Leuven, 3000
    Belgium

    Site Not Available

  • Memory Centre, Polycliniques Brull, CHU de Liège

    Liege,
    Belgium

    Site Not Available

  • empty

    Besançon,
    France

    Site Not Available

  • Besançon,
    France

    Site Not Available

  • Hôpital Pellegrin CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • Dijon,
    France

    Site Not Available

  • Centre Hospitalier Régional Universitaire de Lille

    Lille,
    France

    Site Not Available

  • Hôpital Sainte Marguerite Service de neuro-geriatrie

    Marseille,
    France

    Site Not Available

  • Hôpital Gui de Chauliac - Service de Neurologie du Pr J. Touchon

    Montpellier, 34000
    France

    Site Not Available

  • Centre Mémoire de Ressources et de Recherche Hôpital Pasteur

    Nice,
    France

    Site Not Available

  • Hôpital BROCA

    Paris,
    France

    Site Not Available

  • CHU Reims- Hôpital Sébastopol-Service de médecine interne et Gérontologie Clinique

    Reims,
    France

    Site Not Available

  • Hôpital Hôtel Dieu - Consultation de Gérontologie

    Rennes,
    France

    Site Not Available

  • CHU Purpan

    Toulouse,
    France

    Site Not Available

  • Tours,
    France

    Site Not Available

  • Charité Campus Benjamin Franklin - Universitätsmedizin Berlin - Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie

    Berlin,
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Bochum (Langendreer),
    Germany

    Site Not Available

  • Johann-Wolfgang Goethe-Universität - Klinik für Psychiatrie und Psychotherapie

    Frankfurt,
    Germany

    Site Not Available

  • Klinik für Psychiatrie und Psychotherapie - University Hospital Hamburg-Eppendorf - Dept. of Psychiatry and Psychotherapy

    Hamburg,
    Germany

    Site Not Available

  • Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz

    Heidelberg,
    Germany

    Site Not Available

  • Arzneimittelforschung Leipzig GmbH

    Leipzig,
    Germany

    Site Not Available

  • Abteilung für Geriatrische Psychiatrie - Zentralinstitut für seelische Gesundheit - Universität Heidelberg

    Mannheim,
    Germany

    Site Not Available

  • Munich,
    Germany

    Site Not Available

  • IRCCS Centro San Giovanni di Dio- Fatebenefratelli

    Brescia,
    Italy

    Site Not Available

  • San Martino Hospital - Padiglione Specialita' Fondi

    Genova, 16132
    Italy

    Site Not Available

  • Dept. of Neurosciences TCR - University of Modena and Reggio Emilia

    Modena,
    Italy

    Site Not Available

  • Perugia,
    Italy

    Site Not Available

  • Department of Neuroscience - Section of Neurology - University of Pisa

    Pisa,
    Italy

    Site Not Available

  • Universita' Cattolica del Sacro Cuore

    Rome,
    Italy

    Site Not Available

  • Rome,
    Italy

    Site Not Available

  • Vicenza,
    Italy

    Site Not Available

  • Medisch Centrum Alkmaar

    Alkmaar,
    Netherlands

    Site Not Available

  • Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Blaricum,
    Netherlands

    Site Not Available

  • Memory Clinic UMC St Radboud - Alzheimer Centre

    Nijmegen,
    Netherlands

    Site Not Available

  • Bydgoszcz,
    Poland

    Site Not Available

  • Krakow,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Sopot,
    Poland

    Site Not Available

  • Warsaw,
    Poland

    Site Not Available

  • Wroclaw,
    Poland

    Site Not Available

  • Baracaldo,
    Spain

    Site Not Available

  • Fundaciò ACE- Institut Català de Neurociències Aplicades

    Barcelona,
    Spain

    Site Not Available

  • Hospital Santa Creu i Sant Pau, Servicio de Neurología, Unitad de Memoria

    Barcelona,
    Spain

    Site Not Available

  • Hospital del Mar- Servicio de Neurologia

    Barcelona,
    Spain

    Site Not Available

  • Unitat de Valoració de la Memòria i les Demències - Hospital Santa Caterina - Institut d'Assistència Sanitària

    Girona,
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitairo La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal - Unidad de Geriatria

    Madrid,
    Spain

    Site Not Available

  • Pamplona,
    Spain

    Site Not Available

  • Linkoping,
    Sweden

    Site Not Available

  • Lund,
    Sweden

    Site Not Available

  • Neuropsychiatric Clinic - University Hospital MAS

    Malmo, 20502
    Sweden

    Site Not Available

  • empty

    Mölndal,
    Sweden

    Site Not Available

  • Mölndal,
    Sweden

    Site Not Available

  • Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge

    Stockholm, 141 86
    Sweden

    Site Not Available

  • Memory clinic - Uddevalla Hospital

    Uddevalla,
    Sweden

    Site Not Available

  • Memory Clinic -Geriatric Centre - Academic Hospital

    Uppsala,
    Sweden

    Site Not Available

  • Memory Clinic - Neuropsychology Center - University Hospital

    Basel,
    Switzerland

    Site Not Available

  • Geneva,
    Switzerland

    Site Not Available

  • Research Institute for Care of Elderly - St Martin's Hospital

    Bath,
    United Kingdom

    Site Not Available

  • Fylde Medical Clinic

    Blackpool,
    United Kingdom

    Site Not Available

  • Memory Assessment Centre

    Blackpool,
    United Kingdom

    Site Not Available

  • Wales College of Medicine - Llandough Hospital

    Cardiff,
    United Kingdom

    Site Not Available

  • East Sussex,
    United Kingdom

    Site Not Available

  • Glasgow Memory Clinic - Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • Murray Royal Hospital

    Perth,
    United Kingdom

    Site Not Available

  • Memory Assessment Centre - Moorgreen Hospital

    Southampton,
    United Kingdom

    Site Not Available

  • Kingshill Research Centre - Victoria Hospital

    Swindon,
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.