Exploratory study of S 38093 versus placebo in patients with mild to moderate Alzheimer’s Disease.An international, multi-centre, randomised, double-blind, placebo-controlled phase IIa study.
- Conditions
- Alzheimer's diseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2008-007670-37-GB
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- age 55-85 years (inclusive),
- male or female,
- with cognitive impairment, MMSE 15-26 (inclusive), Clinical Dementia Ratings global score > or = 0.5 (memory sub-score > or = 1.0)
- out-patients, defined for the present study as ambulatory or ambulatory with aids,
- with a minimum of 5 years of school education,
- with a caregiver.
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,
- History or presence of Parkinson’s disease or Parkinsonism,
- Cerebral vascular disorders (stroke, TIA, etc.),
- Epilepsy or solitary seizure
- 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