Vortioxetine Treatment for Depression in Patients with Prodromal vs Mild Alzheimer's Disease: A Six-Month, Open-Label, Observational Study.

BACKGROUND: Depressive symptoms are common in Alzheimer disease (AD) from the prodromal stage. The benefits of antidepressants have been investigated in patients with AD dementia with mixed results. OBJECTIVES: This study aimed to compare the efficacy of vortioxetine in prodromal and mild-to-moderate AD patients with depression, and to assess the comparative effect on secondary measures, including behavioral disturbances, cognitive function, and activities of daily living. PARTICIPANTS: All subjects with AD at a single-center dementia center underwent a standard evaluation with mini-mental state examination (MMSE), basic and instrumental activities of daily living (BADL and IADL), geriatric depression scale (GDS), neuropsychiatric inventory (NPI), and clinical evaluation every six months. MEASUREMENTS: The study specifically assessed patients on vortioxetine with available six-month follow-up data. The changes in GDS, NPI, MMSE, BADL/IADL at six months in the entire AD population and mild-to-moderate AD vs prodromal population were analyzed using repeated measure multivariate analyses. Linear regression analyses were implemented to evaluate baseline demographics and clinical characteristics associated with depressive and cognitive improvements at six months. RESULTS: Out of 680 AD patients, 115 were treated with vortioxetine, and 89 with six-month follow-up data were included in the analyses. A significant improvement at follow-up was observed for GDS, NPI total and sub score items (mood, anxiety, apathy, sleep disturbances, eating abnormalities). Both mild-to-moderate and prodromal AD showed a positive GDS response, whereas mild-to-moderate AD showed a better improvement on total NPI and apathy/nighttime behaviors subitems compared to prodromal AD. Higher baseline GDS score was the only variable associated with higher responses in linear regression analyses. MMSE showed a significant improvement at six months in the entire cohort, with a greater effect in prodromal vs mild-to-moderate AD. Cognitive improvement (i.e., MMSE changes) was associated with cognitive status at baseline but independent of the antidepressant/behavioral changes (i.e., GDS/NPI). CONCLUSIONS: Our results suggest that vortioxetine is highly tolerable and clinically effective in both prodromal and mild-to-moderate AD with depression. Patients with mild-to-moderate AD benefited more from a wide range of behavioral disturbances. The study also showed significant improvement in global cognitive measures, especially in prodromal AD subjects. Further studies are needed to investigate the independent beneficial effect of vortioxetine on depression and cognition in AD.

Assessing frailty at the centers for dementia and cognitive decline in Italy: potential implications for improving care of older people living with dementia.

INTRODUCTION: Frailty is strongly associated with the clinical course of cognitive impairment and dementia, thus arguing for the need of its assessment in individuals affected by cognitive deficits. This study aimed to retrospectively evaluate frailty in patients aged 65 years and older referred to two Centers for Cognitive Decline and Dementia (CCDDs). METHODS: A total of 1256 patients consecutively referred for a first visit to two CCDDs in Lombardy (Italy) between January 2021 to July 2022 were included. All patients were evaluated by an expert physician in diagnosis and care of dementia according to a standardized clinical protocol. Frailty was assessed using a 24-items Frailty Index (FI) based on routinely collected health records, excluding cognitive decline or dementia, and categorized as mild, moderate, and severe. RESULTS: Overall, 40% of patients were affected by mild frailty and 25% of the sample has moderate to severe frailty. The prevalence and severity of frailty increased with decreasing Mini Mental State Examination (MMSE) score and advancing age. Frailty was also detected in 60% of patients with mild cognitive impairment. CONCLUSION: Frailty is common in patients referring to CCDDs for cognitive deficits. Its systematic assessment using a FI generated with readily available medical information could help develop appropriate models of assistance and guide personalization of care.

Technique of injection of onabotulinumtoxin A for chronic migraine: the PREEMPT injection paradigm.

In 2013 the Italian Pharmacy Agency (AIFA) approved onabotulinumtoxin A injection to prevent headaches in adult patients with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine) that has not responded to at least three prior pharmacological prophylaxis therapies and whose condition is appropriately managed for medication overuse. In the present paper we report the method of injection of Onabotulinumtoxin A for chronic migraine based on the PREEMPT paradigm as described by Blumenfeld et al. (Headache 50:1406-1418, 2010) adapted to our clinical setting.