Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer’s Disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study.

Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
MedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders
moderate Alzheimer's disease

Registration Number: EUCTR2011-005862-40-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: 1000

Inclusion Criteria

-Age 55-85 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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