1,720,967 research outputs found

    The ASCOMALVA trial: Association between the cholinesterase inhibitor donepezil and the cholinergic precursor choline alphoscerate in Alzheimer's disease with cerebrovascular injury: Interim results.

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    BACKGROUND: Cholinesterase inhibitors (ChE-Is) are among the drugs more largely used for the treatment of mild-to-moderate symptoms of Alzheimer's disease (AD), but beneficial long-term effects of these compounds on the cognitive, functional, and behavioural symptoms of the disease are small and not always apparent in practice. Preclinical investigations have suggested that association between ChE-Is and the cholinergic precursor choline alphoscerate enhances cholinergic neurotransmission more effectively than single compounds alone. The ongoing clinical trial on the "Effect of association between a ChE-I and choline alphoscerate on cognitive deficits in Alzheimer's disease associated with cerebrovascular injury" (ASCOMALVA) was designed to assess if association of the ChE-I donepezil with choline alphoscerate has a more favourable clinical profile than monotherapy with donepezil alone. METHODS: ASCOMALVA is a double-blind multicentre trial that has completed the first 12 months of observation of 91 patients of the 210 planned. Patients were aged between 56 and 91 years (mean 75 ± 10 years) and were included in the protocol with a MMSE score between 15 and 24. Patients with AD diagnosed according to the DSM IV criteria suffer from ischemic brain damage documented by neuroimaging (MRI and CT scan), with a score≥2 in at least one subfield of the New Rating Scale for Age-Related White Matter Changes (ARWMC). Patients were randomly allotted to an active treatment group (donepezil+choline alphoscerate) or to a reference treatment group (donepezil+placebo) and were examined after 3, 6, 9 and 12 months of treatment. RESULTS: Cognitive functions, patient's daily activities and behavioural symptoms were assessed by the Mini-Mental State Evaluation (MMSE), Alzheimer's Disease Assessment Scale Cognitive subscale (ADAS-cog), Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living (IADL) and Neuropsychiatric Inventory (NPI), of severity and of caregiver distress measures (NPI-F and NPI-D). Patients of the reference group (donepezil+placebo) showed along the course of the 12months of observation, a slight time-dependent worsening of MMSE, ADAS-cog, IADL and NPI-D scores and no changes in the BADL and NPI-F scores. Donepezil plus choline alphoscerate improved compared to donepezil alone the different items analysed except the BADL. CONCLUSIONS: The first results of the ASCOMALVA trial suggest that association of choline alphoscerate to the standard treatment with a ChE-I may represent an option to prolong beneficial effects of cholinergic therapies in AD with concomitant ischemic cerebrovascular injury

    Psychological consequences in victims of maritime piracy: the Italian experience.

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    BACKGROUND AND AIM: Maritime piracy is a worrying phenomenon. Its recurrence in the last few years iscausing several problems to the safety of maritime routes. In spite of the number of seafarers kidnappedand maintained in captivity, psychological/mental disorders developed in victims of these criminal actshave not been investigated. This study has assessed psychological consequences of kidnapping in a groupof Italian seafarers held in captivity from 7 to 10 months. MATERIALS AND METHODS: Four Italian seafarers were examined at the 5th month after release. An initial, semi-structured interview was followed by 2 structured clinical evaluations for assessing the possible presence of psychopathological disorders. Instruments used were the Cognitive Behavioural Assessment (CBA 2.0) and the Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS-DX). RESULTS: All victims showed high scores of state anxiety (56.00 ± 3.36) and social adjustment disorder (12.75 ± 2.21) to CBA 2.0. Moreover, 3 of them revealed traits of anxiety (58.75 ± 8.50) and emotionalinstability (8.25 ± 2.50). Two of them had somatic disorders (63.25 ± 15.94), depression (17.25 ± 4.78) and phobic problems (91.00 ± 7.02). In 3 of 4 victims examined, a PTSD diagnosis was made. Symptomsof recall resulted in higher CAPS-DX (13.00 ± 4.05) scores. CONCLUSIONS: Traumatic experiences such as being kept in captivity by pirates could entail relevant psychopathological disorders in victims and their families. Quality care interventions, aimed to develop paradigms for resilience training, represent a priority. An international partnerships and collaboration between institutions, clinicians and seafarer organisations can be useful to evaluate psychological conditions of these workers

    The Psychological General Well-Being Index (PGWBI) for assessing stress of seafarers on board merchant ships

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    Abstract Background: In their working activity, seafarers are exposed to high levels of stress that should be accuratelyinvestigated, measured, followed up and, if possible, countered. This is also required by regulations recently entered into force such as the Maritime Labour Convention 2006, recommending to consider special physiological or psychological problems created by the shipboard environment. The choice of the tools for this evaluation is challenging, and a common basic standard usable in a large scale should be identified. Aim: The aim of this study was to evaluate: 1) the suitability of the Psychological General Well-Being Index (PGWBI) questionnaire conducted on board for assessing stress in the sailing seafarers, 2) The presenceof stress in seafarers of different categories (deck officers, engine officers, deck crew, engine crew, chiefstewards/catering staff) monitored by the PGWBI. Materials and methods: 162 male seafarers on board of 7 tankers belonging to the same shipping companywere evaluated through the PGWB questionnaire. Analysis of variance (ANOVA) was used to analyse thedifferences in the scores of the questionnaire. Results: Engine officers exhibited significantly higher anxiety levels than the deck or engine crew, andshowed lower satisfaction than the deck crew. Deck and engine officers revealed higher self-control levelsthan the engine crew. Chief stewards/catering staff showed lower vitality levels than the deck crew. Conclusions: Deck or engine officers should achieve a greater self-control than the crew and this is documentedby the present study. Our findings support the view that management responsibility is more often associated with higher levels of stress. In our opinion, the PGWB questionnaire is a reasonable compromise forobtaining a global evaluation of psychological conditions, including stress of seafarers. It should be therefore considered as a large scale tool for assessing the well-being and eventual stress levels of sailing seafarers

    The Effect of the Association between Donepezil and Choline Alphoscerate on Behavioral Disturbances in Alzheimer's Disease: Interim Results of the ASCOMALVA Trial

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    BACKGROUND: Behavioral and psychological symptoms of dementia (BPSD) are a group of psychological reactions, psychiatric symptoms, and behaviors commonly found in Alzheimer's disease (AD). Four clusters of BPSD have been described: mood disorders (depression, anxiety, and apathy), psychotic symptoms (delusions and hallucinations), aberrant motor behaviors (pacing, wandering, and other purposeless behaviors), and inappropriate behaviors (agitation, disinhibition, and euphoria). Most of them are attributed to acetylcholine deficiency. OBJECTIVE: To evaluate if a higher amount of acetylcholine obtained by associating donepezil and choline alphoscerate might have a favorable effect on BPSD. METHODS: BPSD were measured at baseline and after 24 months in 113 mild/moderate AD patients, included in the double-blind randomized trial ASCOMALVA, by the Neuropsychiatric Inventory (NPI). Two matched groups were compared: group A treated with donepezil (10 mg/day) plus choline alphoscerate (1200 mg/day), and group B treated with donepezil (10 mg/day) plus placebo. RESULTS: Data of NPI revealed a significant decrease of BPSD severity and distress of the caregiver in patients of group A compared with group B. Mood disorders (depression, anxiety and apathy) were significantly decreased in subjects treated with donepezil and choline alphoscerate, while their severity and frequency was increased in the other group. CONCLUSIONS: Patients treated with donepezil plus choline alphoscerate showed a lower level of behavioral disturbances than subjects treated with donepezil only, suggesting that the association can have beneficial effect
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