European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
930
10 countries
69
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedDecember 10, 2007
December 1, 2007
September 14, 2005
December 7, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Middelheim Ziekenhuis Lindendreef
Antwerp, Belgium
University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD
Edegem, 2650, Belgium
Memory Clinic University Hospital Gasthuisberg, Neurology Department
Leuven, 3000, Belgium
Memory Centre, Polycliniques Brull, CHU de Liège
Liège, Belgium
Unknown Facility
Besançon, France
Hôpital Pellegrin CHU de Bordeaux
Bordeaux, France
Unknown Facility
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, 34000, 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
Unknown Facility
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
Unknown Facility
Munich, Germany
IRCCS Centro San Giovanni di Dio- Fatebenefratelli
Brescia, Italy
San Martino Hospital - Padiglione Specialita' Fondi
Genova, 16132, Italy
Dept. of Neurosciences TCR - University of Modena and Reggio Emilia
Modena, Italy
Unknown Facility
Perugia, Italy
Department of Neuroscience - Section of Neurology - University of Pisa
Pisa, Italy
Universita' Cattolica del Sacro Cuore
Rome, Italy
Unknown Facility
Rome, Italy
Unknown Facility
Vicenza, Italy
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center
Amsterdam, Netherlands
Unknown Facility
Blaricum, Netherlands
Memory Clinic UMC St Radboud - Alzheimer Centre
Nijmegen, Netherlands
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Sopot, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
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
Unknown Facility
Pamplona, Spain
Unknown Facility
Linköping, Sweden
Unknown Facility
Lund, Sweden
Neuropsychiatric Clinic - University Hospital MAS
Malmo, 20502, Sweden
Unknown Facility
Mölndal, Sweden
Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge
Stockholm, 141 86, Sweden
Memory clinic - Uddevalla Hospital
Uddevalla, Sweden
Memory Clinic -Geriatric Centre - Academic Hospital
Uppsala, Sweden
Memory Clinic - Neuropsychology Center - University Hospital
Basel, Switzerland
Unknown Facility
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
Unknown Facility
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pr. Bruno Vellas
University Hospital Center, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
September 1, 2005
Study Completion
December 1, 2007
Last Updated
December 10, 2007
Record last verified: 2007-12