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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00217763
• Other study ID #: CL-758010
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: December 7, 2007
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHPSpain: Spanish Agency of MedicinesItaly: Ministry of HealthSweden: Medical Products AgencyGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Description:

• Duration of treatment: 18 months

• 3 treatment arms:

Placebo and 2 different doses of active drug.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 930
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 3APS

Locations

Country	Name	City	State
Belgium	Middelheim Ziekenhuis Lindendreef	Antwerp
Belgium	University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD	Edegem
Belgium	Memory Clinic University Hospital Gasthuisberg, Neurology Department	Leuven
Belgium	Memory Centre, Polycliniques Brull, CHU de Liège	Liege
France	Hôpital Pellegrin CHU de Bordeaux	Bordeaux
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	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
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
Italy	IRCCS Centro San Giovanni di Dio- Fatebenefratelli	Brescia
Italy	San Martino Hospital - Padiglione Specialita' Fondi	Genova
Italy	Dept. of Neurosciences TCR - University of Modena and Reggio Emilia	Modena
Italy	Department of Neuroscience - Section of Neurology - University of Pisa	Pisa
Italy	Universita' Cattolica del Sacro Cuore	Rome
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Dept. of Neurology and Alzheimer Center - Vrije Universiteit Medical Center	Amsterdam
Netherlands	Memory Clinic UMC St Radboud - Alzheimer Centre	Nijmegen
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
Sweden	Neuropsychiatric Clinic - University Hospital MAS	Malmo
Sweden	Enheten för klinisk Läkemedelsforskning - Minnesmottagningen - Karolinska Universitetssjukhuset - Huddinge	Stockholm
Sweden	Memory clinic - Uddevalla Hospital	Uddevalla
Sweden	Memory Clinic -Geriatric Centre - Academic Hospital	Uppsala
Switzerland	Memory Clinic - Neuropsychology Center - University Hospital	Basel
United Kingdom	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom,