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. - ND
- Conditions
- Alzheimer`s DiseaseMedDRA version: 12.0Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2009-012035-15-IT
- Lead Sponsor
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method