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Alzheimer's DiseasePhase 3NCT00217763

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

A Phase 3 study testing 3APS in people with Alzheimer's Disease, run by Bellus Health Inc. - a GSK company at 69 sites in 10 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
3APS
How many people
930 participants
Where
69 sitesin 10 countries
Study dates
Sep 2005to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

69 sites in 10 countries.

69 sites in 10 countries

France12 sites

  • Study site

    Besançon

  • Hôpital Pellegrin CHU de Bordeaux

    Bordeaux

  • Study site

    Dijon

  • Centre Hospitalier Régional Universitaire de Lille

    Lille

  • Hôpital Sainte Marguerite Service de neuro-geriatrie

    Marseille

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

    Montpellier, 34000

  • Centre Mémoire de Ressources et de Recherche Hôpital Pasteur

    Nice

  • Hôpital BROCA

    Paris

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

    Reims

  • Hôpital Hôtel Dieu - Consultation de Gérontologie

    Rennes

  • CHU Purpan

    Toulouse

  • Study site

    Tours

Other trials in France

Spain9 sites

  • Study site

    Barakaldo

  • Fundaciò ACE- Institut Català de Neurociències Aplicades

    Barcelona

  • Hospital del Mar- Servicio de Neurologia

    Barcelona

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

    Barcelona

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

    Girona

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitairo La Paz

    Madrid

  • Hospital Universitario Ramón y Cajal - Unidad de Geriatria

    Madrid

  • Study site

    Pamplona

Other trials in Spain

United Kingdom9 sites

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

    Bath

  • Fylde Medical Clinic

    Blackpool

  • Memory Assessment Centre

    Blackpool

  • Wales College of Medicine - Llandough Hospital

    Cardiff

  • Study site

    East Sussex

  • Glasgow Memory Clinic - Golden Jubilee National Hospital

    Glasgow

  • Murray Royal Hospital

    Perth

  • Memory Assessment Centre - Moorgreen Hospital

    Southampton

  • Kingshill Research Centre - Victoria Hospital

    Swindon

Other trials in United Kingdom

Germany8 sites

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

    Berlin

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

    Frankfurt

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

    Hamburg

  • Psychiatrische Universitätsklinik Heidelberg - Sektion für Gerontopsychiatrie - Gedächtnisambulanz

    Heidelberg

  • Gemeinschaftspraxis

    Langendreer

  • Arzneimittelforschung Leipzig GmbH

    Leipzig

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

    Mannheim

  • Study site

    Munich

Other trials in Germany

Italy8 sites

  • IRCCS Centro San Giovanni di Dio- Fatebenefratelli

    Brescia

  • San Martino Hospital - Padiglione Specialita' Fondi

    Genova, 16132

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

    Modena

  • Study site

    Perugia

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

    Pisa

  • Universita' Cattolica del Sacro Cuore

    Rome

  • Study site

    Rome

  • Study site

    Vicenza

Other trials in Italy

Sweden7 sites

  • Study site

    Linköping

  • Study site

    Lund

  • Neuropsychiatric Clinic - University Hospital MAS

    Malmö, 20502

  • Study site

    Mölndal

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

    Stockholm, 141 86

  • Memory clinic - Uddevalla Hospital

    Uddevalla

  • Memory Clinic -Geriatric Centre - Academic Hospital

    Uppsala

Other trials in Sweden

Poland6 sites

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Sopot

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Belgium4 sites

  • Middelheim Ziekenhuis Lindendreef

    Antwerp

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

    Edegem, 2650

  • Memory Clinic University Hospital Gasthuisberg, Neurology Department

    Leuven, 3000

  • Memory Centre, Polycliniques Brull, CHU de Liège

    Liège

Other trials in Belgium

Netherlands4 sites

  • Medisch Centrum Alkmaar

    Alkmaar

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

    Amsterdam

  • Study site

    Blaricum

  • Memory Clinic UMC St Radboud - Alzheimer Centre

    Nijmegen

Other trials in Netherlands

Switzerland2 sites

  • Memory Clinic - Neuropsychology Center - University Hospital

    Basel

  • Study site

    Geneva

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed description
  • Duration of treatment: 18 months
  • 3 treatment arms:

Placebo and 2 different doses of active drug.

Being tested
3APS
Keywords
Dementia, Alzheimer's disease
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3APSDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Study completionDec 2007 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
930 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217763
Sponsor's protocol ID
CL-758010
Status last verified
Dec 2007
First submitted
14 Sep 2005
Last updated
10 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3APS in people with Alzheimer's Disease, run by Bellus Health Inc. - a GSK company at 69 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France, Spain, United Kingdom, Germany, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.

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