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 Seguridad y eficacia de S 38093 y donepezilo, en pacientes con enfermedad de Alzheimer leve a moderada, durante 4 semanas. Estudio de fase II, de asociación, internacional, multicéntrico, aleatorizado, doble ciego, controlado frente a placebo.
- Conditions
- Alzheimer's Disease. Enfermedad de AlzheimerMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2009-012035-15-ES
- Lead Sponsor
- aboratorios Servier S.
- 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, defined for the present study as ambulatory or ambulatory with aids
- With a caregiver
- With a minimum of 4 years of school education
- Cognitive impairment (Mini Mental State Examination (MMSE) = 15-26)
- Extensive metaboliser for cytochrome 2C19
- Treated with donepezil for at least 6 months, at the dose of 10 mg/day for at least 4 months
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