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 of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Bruno Vellas
Scientific
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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 711 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/08/2011 |
| Date of final enrolment | 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
31059
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
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.
