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

Conditions: mild to moderate Alzheimer’s disease
MedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-024626-37-HU

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

- Age 55-85 years (both inclusive)
- School education = 4 years (i.e. formal schooling)
- Have a responsible informant- DSM-IV-TR criteria for Dementia of the Alzheimer’s Type
-NINCDS-ADRDA criteria for probable AD
-Total score of Mini-Mental State Examination (MMSE) between 15 and 24, both inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 510

Exclusion Criteria

- In-patients
- Illiterate patients
- Female patients of child-bearing potential
-Dementia due to any condition other than AD
- History or presence of Parkinson’s disease or Parkinsonism
- Cerebral vascular disorders
- Major neurological or neurodegenerative conditions associated with significant cognitive impairment such as Multiple Sclerosis or Huntington’s Disease
- Major psychiatric conditions
- Major depressive disorder within the two months prior to inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Efficacy and safety;Primary end point(s): The Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) 11-items.;Timepoint(s) of evaluation of this end point: From W0 to W48;Main Objective: to assess the efficacy of S 38093 versus placebo after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with mild to moderate Alzheimer's disease.

Secondary Outcome Measures