ABSTRACT
The implementation of effective interventions for neuropsychiatric symptoms (NPS) is perceived as one of the most pressing research priorities in the field of dementia and one of the main unmet needs from the perspective of affected individuals and their caregivers and relatives. Nevertheless, to date, only a relatively marginal part of dementia research has focused on NPS. This study aimed to describe and discuss the state of the art concerning the identification and development of new pharmacological treatments for NPS in dementia. A review of 320 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials enrolling patients with dementia were selected. Only studies adopting clinical measures of NPS frequency and/or severity as primary outcome were retained and analyzed. Overall, only a minority of ongoing phase 1, 2, 3 and 4 protocols on dementia (i.e., 9.0%) is primarily targeting NPS. Most of these studies are adopting a placebo-controlled parallel assignment design, testing oral compounds, and targeting specific NPS (mostly agitation and/or aggression). A total of 3,445 subjects with dementia will tentatively be recruited in these trials. The methodologies adopted in these studies, the characteristics of the tested interventions, the eligibility criteria, and the operational definitions of NPS are presented and discussed. The relevance of NPS is not yet matched by an adequate research effort. The current tendency at privileging disease-modifying approaches and other symptoms of dementia and the methodological complexity of studying NPS are still substantially contributing to the gap between research activities and clinical needs.
Subject(s)
Dementia/drug therapy , Primary Health Care/methods , Psychomotor Agitation/drug therapy , Aged , Aged, 80 and over , Antipsychotic Agents/adverse effects , Antipsychotic Agents/therapeutic use , Caregivers/psychology , Clinical Trials as Topic , Dementia/psychology , Female , Humans , Longitudinal Studies , Male , Neuropsychological TestsABSTRACT
UNLABELLED: Chemotherapy-induced nausea and vomiting is one of the major side effects of antiblastic treatment in cancer patients, seriously affecting both the compliance of the patient to therapy and his or her quality of life. OBJECTIVE: The Authors present their experience in the use of ondansetron in 47 patients receiving 186 cycles of chemotherapy for breast or genital neoplasms. RESULTS: Successful control of vomiting was achieved in the first 24 hours, in 74% of the cycles containing cisplatin and 82% of the cycles without cisplatin, if ondansetron was used. On delayed vomiting the difference in results was not as striking as on acute emesis. CONCLUSIONS: The major side effects with ondansetron were headaches (42.4%) and constipation (48.9%). As expected, no extra-pyramidal symptoms were observed in this group, versus 13.3% of the patients treated with metoclopramide.
