Efficacy and safety of S 38093 versus placebo in patients with mild to moderate Alzheimer's disease

ISRCTN	ISRCTN89039808
DOI	https://doi.org/10.1186/ISRCTN89039808
EudraCT/CTIS number	2010-024626-37
Secondary identifying numbers	CL2-38093-011

Submission date: 20/05/2011
Registration date: 28/07/2011
Last edited: 20/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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

Contact information

Prof Bruno Vellas
Scientific

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

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study hypothesis	To demonstrate efficacy of at least one dose of S 38093 as compared to placebo on primary endpoint
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	22/08/2011
Overall study end date	30/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
Total final enrolment	711
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 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

Study participating centre

CHU La Grave-Casselardit

Toulouse
31059
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication plan: Summary results are published in https://clinicaltrials.servier.com.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Basic results			20/04/2020	No	No

Editorial Notes

20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
30/11/2017: Results summary added.