Author/Authors :
Gasbarrini، نويسنده , , Giovanni and Stefanini، نويسنده , , Giuseppe and Addolorato، نويسنده , , Giovanni and Foschi، نويسنده , , Francesco and Ricci، نويسنده , , Cristina and Bertolotti، نويسنده , , Paolo and Voltolini، نويسنده , , Gianbattista and Bonavita، نويسنده , , Ermanno and Bertoncelli، نويسنده , , Roberto and Renzi، نويسنده , , Giorgio and Bianchini، نويسنده , , Giuseppe and Bonaiuto، نويسنده , , Salvatore and Giannandrea، نويسنده , , Elvio and Cavassini، نويسنده , , Giovanni and Mazzini، نويسنده , , Vincenzo and Chioma، نويسنده , , Vittorio and Marzara، نويسنده , , Giovanni and DʹAddetta، نويسنده , , Giovanni and Totaro، نويسنده , , Giuseppe and Dalmonte، نويسنده , , Edoardo and Tassini، نويسنده , , Donatella and Giungi، نويسنده , , Franco and De Nitto، نويسنده , , Claudio and Di Fazio، نويسنده , , Giorgio and Tessitore، نويسنده , , Andrea and Guadagnino، نويسنده , , Massimo and Tessitore، نويسنده , , Enrico and Spina، نويسنده , , Pietro and Luppi، نويسنده , , Mauro and Bignamini، نويسنده , , Angelo and Peracino، نويسنده , , Lucia and Fiorentino، نويسنده , , Maddalena and Beun-Garbe، نويسنده , , Dominique and Poli، نويسنده , , Aldo and Ambrosoli، نويسنده , , Laura and Girardello، نويسنده , , Roberto، نويسنده ,
Abstract :
In order to confirm the efficacy and safety of posatirelin (l-pyro-2-aminoadipyl-l-leucyl-l-prolinamide), a synthetic peptide having cholinergic, catecholaminergic and neurotrophic activities, a multicentre, double-blind, controlled study versus placebo was planned in elderly patients suffering from Alzheimerʹs disease and vascular dementia, according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimerʹs Disease and Related Disorders Association (NINCDS–ADRDA) and National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et lʹEnseignement en Neurosciences (NINDS–AIREN) criteria, respectively. The trial consisted of a 2-week run-in phase with placebo administered once a day orally, followed by a double-blind period of 3 months, with posatirelin or placebo administered once a day intramuscularly. Efficacy was assessed using the Gottfries–Bråne–Steen (GBS) Rating Scale (primary variable) and the Rey Memory Test (secondary variable). Laboratory tests, vital signs and adverse events were monitored. A total of 360 patients were randomized, the intent-to-treat sample (ITT) being made up of 357 patients and the per protocol sample (PP) of 260 patients. Both pragmatic and explanatory analyses showed significant differences between treatment groups in the GBS Rating Scale and the Rey Memory Test, with no difference in the two types of dementia. No difference between treatments was observed in safety variables, the incidence of adverse events in the posatirelin group being 7.3%. The study confirms previous results showing that treatment with posatirelin can improve cognitive and functional abilities of patients suffering from degenerative or vascular dementia.
