moderate Alzheimer's disease MedDRA version: 17.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disability Assessment for Dementia (DAD);Timepoint(s) of evaluation of this end point: W0 and W24 | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Finland, Germany, Italy, Mexico, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed