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

Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease. A 24- week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024626-37-DE

Enrollment

600

Registered

2011-07-04

Start date

2011-09-09

Completion date

Unknown

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild to moderate Alzheimer’s disease MedDRA version: 14.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: S38093 Product Code: S38093-2 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: S38093 Current Sponsor code: S38093-2 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Secondary

Measure	Time frame
Secondary end point(s): Disability Assessment for Dementia (DAD) ;Timepoint(s) of evaluation of this end point: From W0 to W48	—

Countries

Australia, Brazil, Bulgaria, Chile, Czech Republic, France, Germany, Hungary, Mexico, Portugal, Romania, Russian Federation, South Africa

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026