Condition category
Mental and Behavioural Disorders
Date applied
20/05/2011
Date assigned
28/07/2011
Last edited
05/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bruno Vellas

ORCID ID

Contact details

C.H.U. La Grave-Casselardit
Service de Medecine Interneet de Gerontologie Clinique
170 Avenue de Casselardit
TSA 60033
Toulouse
31059
France

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 below 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 measures

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

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

C.H.U. 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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes