Additional identifiers
EudraCT number
2010-024626-37
ClinicalTrials.gov number
Protocol/serial number
CL2-38093-011
Study information
Scientific title
Efficacy and safety of three doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer's disease
Acronym
Study hypothesis
To demonstrate efficacy of at least one dose of S 38093 as compared to placebo on primary endpoint
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Mild to moderate Alzheimer's disease
Intervention
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
Intervention type
Drug
Phase
Phase II
Drug names
S 38093
Primary outcome measure
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
Secondary outcome measures
1. Disability Assessment for Dementia (DAD)
2. DAD will be assessed at week 0, week 24 and week 48
Overall trial start date
22/08/2011
Overall trial end date
30/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
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
Recruitment start date
22/08/2011
Recruitment end date
30/04/2014
Locations
Countries of recruitment
Australia, Brazil, Bulgaria, Chile, Czech Republic, France, Germany, Hungary, Mexico, Portugal, Romania, Russian Federation, South Africa
Trial participating centre
CHU La Grave-Casselardit
Toulouse
31059
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL2-38093-011_synopsis_report.pdf
Publication list