RESUMO
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 Alzheimer's disease and vascular dementia, according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement 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.
RESUMO
Between October 1992 and July 1993, 11 Northern Italian geriatric departments systematically screened 1386 inpatients hospitalized for at least 10 days. Of those screened, 74% (N = 1019) were excluded by one or more of 7 exclusion criteria; 32% (N = 118) of the 367 remaining subjects failed to meet more than 1 of 8 inclusion criteria. The 11 Geriatric Evaluation Units (GEUs) examined the remaining eligible 249 inpatients with a uniform comprehensive geriatric assessment (CGA) plan, which included a number of validated assessment scales. Of those evaluated, 39% (N = 97) were ineligible for the study because of being unwilling, noncompliant, too sick or "not truly frail", and the remaining 152 (11% of all patients screened) were randomly enrolled in two groups; 79 were assigned to the GEU (experimental group), and 73 to standard care in the National Health Care System (control group). At entry there was no statistically significant difference between the two groups. At 6 months, preliminary results are encouraging; GEU patients had a lower mortality than controls (2 vs 8, 2.5% vs 10.9%; p < 0.05). Slight differences were seen in both clinical-cognitive-affective-functional status and the use of health and social care resources. Only 3 subjects dropped out, 8 refused further follow-up, and 3 went to a nursing-home. We conclude that a standardized selection plan can recognize frail elderly inpatients and that GEU care seems to achieve good results.
