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 disease
MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease

Registration Number: EUCTR2008-007670-37-AT

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

Inclusion Criteria

- 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

Exclusion Criteria

- 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
Main Objective: - safety of S 38093 as compared to placebo, <br>- efficacy of S 38093 on cognitive performances, on neuropsychiatric symptoms and symptoms associated with dementia (including apathy and daytime sleepiness) and on the Clinical Global Impression of Change as compared to placebo,<br>- S 38093 plasma concentrations which will be used for a population pharmacokinetic analysis;Secondary Objective: ;Primary end point(s): - Safety criteria: adverse events, vital signs, body weight, 12 lead-ECG, biological laboratory examinations.<br>- Efficacy criteria: Cognitive tasks using a computerised test battery, Clinical Global Impression of Change (ADCS-CGIC), Neuro-Psychiatric Inventory (NPI), Apathy Evaluation Scale (AES), Epworth Sleepiness Scale (ESS).<br>- S 38093 plasma concentrations

Secondary Outcome Measures