Mild Cognitive Impairment MedDRA version: 5.1 Level: PT Classification code 10027175
Conditions
Interventions
Product Code: S 18986
Pharmaceutical Form: Capsule*
Current Sponsor code: S 18986-11
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Be aged >or= 55 years, 7 years of education at least, LM II of WMS-Revised with 1.5 SD below norm as function of age, MMSE >or= 24, global CDR=0.5 (memory box >or= 0.5), not sufficiently impaired to meet dementia (DSM IV).AchEI are to be stopped at least 3 months before selection. SSRI or SNRI for depressive symptoms accepted if stabilized symptoms for at least 3 consecutive months before selection; the same for low dose of anxiolytic or hypnotic, used as sleep aid. 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
Exclusion criteria: - Patient sufficiently impaired to meet DSM-IV criteria for diagnosis of dementia - Vascular disorder (modified Hachinski Ischemic Scale score > 4), - History of Major Depressive Episode or other major psychiatric disorder within 12 months prior to randomization (DSM-IV), - Depression symptoms assessed with the Geriatric Depression Scale, GDS-15> 6 , - Hamilton Rating Scale for Anxiety, HAM-A scale >15 , - Any other previous or ongoing chronic or recurrent disease of the central nervous system or psychiatric diseases, that may have an impact on cognitive performance, left to the AD research clinician’s judgement, - Concomitant treatments known to have central effects except for restricted treatments such as : . SSRI or SNRI administered for stabilized depressive symptoms for at least 3 months (same treatment and same daily dose for at least 3 consecutive months before selection with treatment to be continued at the same dose for the study duration) and . Low dose of anxiolytic or hypnotic used as sleep aid (benzodiazepine or other, e.g. 2 mg of lorazepam, 0.25 mg of alprazolam, 15 mg of oxazepam or 10 mg of temazepam, same treatment and same nocte dose for at least 3 consecutive months before selection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate a superiority of at least one dose of S 18986 vs. placebo on verbal episodic memory performance in patients with MCI over 12 months. ;Secondary Objective: - Demonstrate a superiority of at least one dose of S 18986 vs. placebo of non verbal episodic memory and other cognitive domains performance in patients with MCI over 12 months. - Demonstrate a superiority of at least one dose of S 18986 vs. placebo in the activities of daily living, the patient self-perception of his/her memory impairment, and the clinician global impression of change in patients with MCI over 12 months. - Show a reduction or a stabilization of hippocampal and whole brain atrophy using MRI in MCI patients treated with S 18986 for 12 months vs. placebo. - Show a lower number of conversion to AD with S 18986 vs. placebo over 12 months. - Assess safety and acceptability of S 18986 in patients with MCI over 12 months. - Collect plasma concentrations of S 18986 and its metabolite Y 1255 in order to compare the level with previous studies.;Primary end point(s): Trial I-V total score (maximum score: 75, delta = 4 words) of the Rey Auditory Verbal learning Test (RAVLT) | — |
Countries
Germany, United Kingdom
Outcome results
None listed