Efficacy of 15 mg and 50 mg of S 18986 on cognitive symptoms in Mild Cognitive Impairment patients treated over a 12-month oral administration period.An international multicentre, 3 parallel groups, randomised, double blind, placebo-controlled phase II study.

Institut de Recherches Internationales Servier0 个研究点目标入组 450 人开始时间: 2005年2月14日最近更新: 2012年5月1日

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•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

•- 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).

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