Clinical trial NCT00217763: European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
Official title: A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Dementia
Alzheimer's disease
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 930
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: * Duration of treatment: 18 months
* 3 treatment arms:

Placebo and 2 different doses of active drug.

Eligibility 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.

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