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ISRCTN
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ISRCTN89039808
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ClinicalTrials.gov identifier
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Public title
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Efficacy and safety of S 38093 versus placebo in patients with mild to moderate Alzheimer's disease
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Scientific title
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Efficacy and safety of 3 doses of S 38093 (2, 5 and 20mg/day) versus placebo in patients with mild to moderate Alzheimer's disease
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Acronym
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N/A
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Serial number at source
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CL2-38093-011
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Study hypothesis
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To demonstrate efficacy of at least one dose of S 38093 as compared to placebo on primary endpoint
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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A 24 week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24 week extension period
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Countries of recruitment
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Australia, Brazil, Bulgaria, Chile, Czech Republic, France, Germany, Hungary, Mexico, Portugal, Romania, Russian Federation, South Africa
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Disease/condition/study domain
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Mild to moderate Alzheimer's disease
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Participants - inclusion criteria
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1. Age 55-85 years
2. School education more than or equal to 4 years
3. Able to perform neuropsychological tests
4. Have adequate visual and auditory acuity with the usual corrective aids to allow neuropsychological testing
5. Have a responsible informant Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Dementia of the Alzheimer's type
6. National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD)
7. Mini-Mental State Examination (MMSE) between 15 and 24
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Participants - exclusion criteria
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1. Inpatients
2. Female patients of child-bearing potential
3. Dementia due to any condition other than AD
4. History of epilepsy or solitary seizure
5. History or presence of Parkinson's disease or Parkinsonism
6. Major neurological or neurodegenerative conditions associated with significant cognitive impairment such as Multiple Sclerosis or Huntington's Disease
7. Major psychiatric conditions
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Anticipated start date
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22/08/2011
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Anticipated end date
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30/04/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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1. 2, 5 or 20mg/day of S 38093 or placebo, Orally, during a 24-week treatment period + 24-week treatment extension period
2. A 2-6-week selection period without study treatment will be followed by a 24-week double-blind treatment with 4-parallel groups (doses : 2, 5 and 20 mg/day of S38093 and placebo) and a 24-week optional treatment extension period (patients on placebo will be re-randomised to S 38093 2; 5 or 20mg) and a 2-week follow-up period
3. One tablet of S 38093 (2, 5 or 20mg) or placebo will be taken orally, once a day, during study participation from inclusion visit +1 until follow-up period
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Primary outcome measure(s)
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1. The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) 11-items 2. ADAS-Cog will be assessed at week 0, week 24, week 36 and week 48
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Secondary outcome measure(s)
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1. Disability Assessment for Dementia (DAD)
2. DAD will be assessed at week 0, week 24 and week 48
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Sources of funding
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Institute of Research Servier International (Institut de Recherches Internationales Servier) (France)
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Trial website
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Publications
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Contact name
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Prof
Bruno
Vellas
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Address
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C.H.U. La Grave-Casselardit
Service de Medecine Interneet de Gerontologie Clinique
170 Avenue de Casselardit
TSA 60033
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City/town
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Toulouse
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Zip/Postcode
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31059
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Country
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France
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Sponsor
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Institute of Research Servier International (Institut de Recherche Internationales Servier) (France)
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Address
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c/o Ms Valerie Fautrier
6 Place des Pleiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Sponsor website:
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http://www.servier.com/
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Date applied
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20/05/2011
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Last edited
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28/07/2011
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Date ISRCTN assigned
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28/07/2011
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