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Safety and efficacy of S 38093 and donepezil, during 4 weeks, in patients with mild to moderate Alzheimer's Disease. An international, multi-centre, randomised, double-blind, placebo controlled, phase II add-on study

Safety and efficacy of S 38093 and donepezil, during 4 weeks, in patients with mild to moderate Alzheimer's Disease. An international, multi-centre, randomised, double-blind, placebo controlled, phase II add-on study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012035-15-PT
Enrollment
100
Registered
2009-07-28
Start date
2009-10-07
Completion date
Unknown
Last updated
2012-06-26

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

Conditions

Alzheimer's Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease

Interventions

Product Name: S38093 Product Code: S38093 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S38093 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Ph

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female - Age 55-85 years - Out patients - With a caregiver - With a minimum of 4 years of school education - Cognitive impairment (MMSE between 15 and 26) - Extensive metaboliser for cytochrome 2C19 - Treated with donepezil 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Dementia due to any condition other than Alzheimer's Disease - Epilepsy or solitary seizure - History or presence of Parkinson's disease or Parkinsonism - Cerebral vascular disorders (stroke, TIA, etc.) - Advanced, severe, progressive or unstable disease of any type that could interfere with safety and efficacy assessments or put the patient at particular risk

Design outcomes

Primary

MeasureTime frame
Main Objective: safety of S 38093 in combination with donepezil;Secondary Objective: - efficacy after 4 weeks of co-administration of S 38093 and donepezil - pharmacokinetic characteristics of S 38093 added to donepezil;Primary end point(s): Safety criteria: - Adverse events - Vital signs - 12 lead-ECG - Biological laboratory examinations—

Countries

Italy, Portugal, Spain

Outcome results

None listed

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