ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance.

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. Funding: None.

Gam-COVID-Vac (Sputnik V) and Pfizer-BioNTech Vaccines Adverse Events following Immunization in Patients Affected by Parkinson's Disease and Multiple Sclerosis: A Longitudinal Study.

The Republic of San Marino COVID-19 vaccination campaign used Gam-COVID-Vac and Pfizer-BioNTech vaccines. To assess adverse events following immunization (AEFIs), approximately 6000 vaccine recipients were monitored by the ROCCA study, including subgroups with Parkinson's Disease (PD) and Multiple Sclerosis (MS). The purpose of this study is to evaluate short-term AEFIs through a 1-month follow-up. We conducted a longitudinal study, using active surveillance to evaluate the safety profiles of COVID-19 vaccines in PD and MS patients. Participants were actively administered a standardized online questionnaire to collect information on AEFIs. Among all PD and MS assisted by the San Marino hospital, a total of 82 patients completed the questionnaires. One week after administration of the first dose, vaccine recipients reported AEFIs in 26% of cases in the PD group, 67% in the MS group, and 68% in the control group. Participants reported slightly higher rates of AEFIs after dose 2 compared with dose 1, being 29%, 75%, and 78% for PD, MS, control group, respectively. Most of the reported symptoms were mild. Patients with PD and MS reported few AEFIs after administration of the COVID-19 vaccines. The frequency of AEFIs in the PD population was significantly lower than in the control group.

Standardization and normative data for a new test of visual long-term recognition memory.

The assessment of recognition memory is useful in several neurological conditions, but normative data for visual recognition memory of complex figures are still missing for the Italian population. The aim of this study is to present a new short test of visual recognition memory that consists in a supplementary task to be administered after the free delayed recall trial of the Modified Taylor Complex Figure (MTCF). The MTCF-Recognition Trial (MTCF-RT) includes 10 tables, each with a sub-component of the MTCF coupled with two interfering stimuli. Participants are asked to point, for each triplet, the item that was part of the original picture. Normative data were collected from a sample of 280 healthy Italian native speakers ranging in age from 18 to 89 years. The mean recognition score on the MTCF-RT was 9.125 ± 0.996. Results from multiple regression analyses showed that age and education (but not gender) were significant predictors of performance. Therefore, we provided correction grids to adjust raw scores for age and education and computed equivalent scores for the use of the MTCF-RT in the clinical assessment of recognition memory.

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance.

BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18-89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None.

Cognitive phenotypes in Parkinson's disease: A latent profile analysis.

OBJECTIVES: Neurocognitive disorders in Parkinson's disease (PD) are common and heterogeneous. The aim of this study was to use a data-driven method to describe different cognitive phenotypes in PD and to explore anxiety, depression, and motor disturbances across the different cognitive profiles. METHOD: Latent profile analysis was applied to the neuropsychological performances of 65 patients with idiopathic PD assessed by means of a battery of tests that encompass measures of attention, memory, executive functions, social cognition, language, and visuospatial abilities. RESULTS: A three-cluster model produced the best solution: Cluster A (21.54%) included patients with intact cognition or with a relatively slight cognitive impairment in memory and executive functioning; Cluster B (53.85%) included patients with an intermediate level of cognitive impairment; and Cluster C (24.61%) included patients with the most severe cognitive impairment, with greater deficit compared to Cluster B in executive functioning, and, notably, in tasks with a predominantly posterior cortical basis (naming and visuospatial abilities). The three subgroups did not differ in terms of age, gender, disease duration, motor symptom severity or side of onset, levodopa equivalent daily dose, level of anxiety, or depression; however, patients from Cluster C showed greater impairment than patients from Cluster A in measures of everyday functioning. CONCLUSIONS: We presented a qualitative description of three distinct cognitive phenotypes emerging from a sample of 65 PD patients. The three clusters seem to be related to daily functioning but are independent from the stage of disease, motor functioning, anxiety, and depression. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Facial expressions recognition and discrimination in Parkinson's disease.

Emotion processing impairment is a common non-motor symptom in Parkinson's Disease (PD). Previous literature reported conflicting results concerning, in particular, the performance for different emotions, the relation with cognitive and neuropsychiatric symptoms and the affected stage of processing. This study aims at assessing emotion recognition and discrimination in PD. Recognition of six facial expressions was studied in order to clarify its relationship with motor, cognitive and neuropsychiatric symptoms. Sensitivity in discriminating happy and fearful faces was investigated to address controversial findings on impairment in early stages of emotion processing. To do so, seventy PD patients were tested with the Ekman 60 Faces test and compared with 46 neurologically unimpaired participants. Patients' performances were correlated with clinical scales and neuropsychological tests. A subsample of 25 PD patients and 25 control participants were also tested with a backward masking paradigm for sensitivity in happiness and fear discrimination. Results showed that PD patients were impaired in facial emotion recognition, especially for fearful expressions. The performance correlated with perceptual, executive and general cognitive abilities, but facial expression recognition deficits were present even in cognitively unimpaired patients. In contrast, patients' sensitivity in backward masking tasks was not reduced as compared to controls. Taken together our data demonstrate that facial emotion recognition, and fear expression in particular, is critically affected by neurodegeneration in PD and related to cognitive abilities; however, it appears before other cognitive impairments. Preserved performances in discriminating shortly presented facial expressions, suggest unimpaired early stages of emotion processing.

Selective defects of face familiarity associated to a left temporo-occipital lesion.

Acquired prosopagnosia is usually a consequence of bilateral or right hemisphere lesions and is often associated with topographical disorientation and dyschromatopsia. Left temporo-occipital lesions sometimes result in a face recognition disorder but in a context of visual object agnosia with spared familiarity feelings for faces, usually in left-handers. We describe a patient with a left temporo-occipital hemorrhagic lesion unexpectedly resulting in a deficit of face familiarity, which could represent a mild form of associative prosopagnosia. Our patient failed to feel familiarity feelings even with very well-known famous faces but had neither visual object agnosia nor defects with semantics or naming of celebrities. This was confirmed even when the patient was re-tested a year later. We speculate that a graded lateralization of face processing could be at the basis of occasional cases of prosopagnosia.

EEG microstate complexity for aiding early diagnosis of Alzheimer's disease.

The dynamics of the resting brain exhibit transitions between a small number of discrete networks, each remaining stable for tens to hundreds of milliseconds. These functional microstates are thought to be the building blocks of spontaneous consciousness. The electroencephalogram (EEG) is a useful tool for imaging microstates, and EEG microstate analysis can potentially give insight into altered brain dynamics underpinning cognitive impairment in disorders such as Alzheimer's disease (AD). Since EEG is non-invasive and relatively inexpensive, EEG microstates have the potential to be useful clinical tools for aiding early diagnosis of AD. In this study, EEG was collected from two independent cohorts of probable AD and cognitively healthy control participants, and a cohort of mild cognitive impairment (MCI) patients with four-year clinical follow-up. The microstate associated with the frontoparietal working-memory/attention network was altered in AD due to parietal inactivation. Using a novel measure of complexity, we found microstate transitioning was slower and less complex in AD. When combined with a spectral EEG measure, microstate complexity could classify AD with sensitivity and specificity > 80%, which was tested on an independent cohort, and could predict progression from MCI to AD in a small preliminary test cohort of 11 participants. EEG microstates therefore have potential to be a non-invasive functional biomarker of AD.