Efficacy and safety of S 38093 versus placebo, in co-administration with donepezil in patients with moderate Alzheimer's Disease

Conditions: moderate Alzheimer's disease
MedDRA version: 17.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-005862-40-DE

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

-Age 55-90 years (both inclusive)
-School education = 4 years (i.e. formal schooling),
-DSM-IV-TR criteria for Dementia of the Alzheimer’s Type
. Memory impairment and
. One or more cognitive disturbances: Aphasia, apraxia, agnosia or disturbance in executive functioning.
. Significant impairment of social or occupational functioning due to cognitive deficits, with a decline from previous functioning,
. Gradual onset of disease and continuous cognitive decline,
. Deficit not due to delirium or any other medical cause.
-NINCDS-ADRDA criteria for probable AD
. Dementia established by clinical and confirmed by neuropsychological examination,
. Progressive cognitive impairment,
. Cognitive impairment in two or more areas of cognition,
. Absence of other diseases possibly inducing dementia.
-Total score of Mini-Mental State Examination (MMSE) between 12 and 20, both inclusive.
Modified Hachinski Scale = 4,
-Geriatric Depression Rating Scale-15 (GDS) score = 5
-Donepezil treatment (tablets of 5 or 10 mg/d) for at least 4 months before selection, and at a stable dose of 10 mg/day for at least 3 months before the selection visit.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

Exclusion Criteria

In-patients (e.g. hospitalised patients, institutionalised patients [patients in day care centers or in institutions where only meals and medications are provided, can be selected]),
- Patients not being able to read or write before onset of Alzheimer's Disease,
- Female patients of child-bearing potential (e.g., not menopausal for at least 2 years prior to selection or not having had hysterectomy),
- Dementia due to any condition other than AD
- History of epilepsy or solitary seizure (generalised or partial),
Schizophrenia, Schizoaffective Disorder, Bipolar Disorders,
- Major depressive disorder within the two months prior to inclusion. Patients with AD and associated stable depressive symptoms (stable for at least 2 months prior to inclusion) can be selected.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of 3 fixed doses of <br>S 38093 (2, 5 and 20mg/ day) versus placebo, in co-administration with donepezil 10 mg/day, after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with moderate Alzheimers' Disease;Secondary Objective: Efficacy and safety;Primary end point(s): Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) 11 items;Timepoint(s) of evaluation of this end point: W0, W12 and W24

Secondary Outcome Measures