EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale.

OBJECTIVES: The Zarit Caregiver Burden Scale, translated and validated into Spanish, is sensitive to the application of a Psychoeducational Intervention Program (PIP) for the prevention and reduction of burden in caregivers of Alzheimer's disease (AD) patients (EDUCA study). The data obtained in EDUCA was used to reanalyse its psychometric properties and the cut-off points of the Zarit scale. METHODS: The scale was administered to 115 caregivers of patients with AD who were randomised to receive a PIP or standard care for four months. Internal reliability and a factorial analysis of principal components were assessed, and the impact of PIP on each of the subscales was evaluated. A cut-off point was defined for the Zarit scale to identify the caregivers most sensitive to receiving a PIP. RESULTS: A good internal reliability (Cronbach alpha coefficient of 0.92) was obtained, with three principal components (burden, competency and dependence) explaining 54.75% of the variance. The application of PIP showed statistically significant differences versus standard care for the dependence subscale (p = 0.0082) (p = 0.062 for the burden scale). The Zarit scale cut-off points which combine better sensitivity and specificity were 56/57 and 59/60, for the 5/6 and 6/7 cut-off points of the General Health Questionnaire (GHQ-28) scale, respectively. CONCLUSIONS: This study confirms the good psychometric properties of the Zarit scale found in previous studies. The dependence component appeared to be most influenced by the application of a PIP in the clinical trial. Caregivers with a Zarit scale score of 60 or more benefit most from the PIP.

[Rivastigmine solution prescribing habits in patients with Alzheimer-type dementia in Spain (RIVASOL study)]. / Hábitos de prescripción de rivastigmina en solución en pacientes con demencia de tipo Alzheimer en España (estudio RIVASOL).

INTRODUCTION: One of the most notable advances in the treatment of Alzheimer's disease today is the appearance of the drugs rivastigmine, donepezil, galanthamine and memantine. AIMS. We attempt to throw light on the dosage regimens, degree of effectiveness and safety profile of rivastigmine solution by means of a retrospective, descriptive, cross-sectional study known as the RIVASOL study. PATIENTS AND METHODS: The study involved 1516 patients (1386 of whom were evaluable) who had been diagnosed with Alzheimer-type dementia (ATD) according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV); these patients, who were selected by 157 participating physicians (neurologists, psychiatrists and geriatricians), gave their informed written consent and had been receiving treatment with rivastigmine solution over the past six months. The main variable was the rivastigmine solution treatment regimen and the secondary variables included socio-demographic data, health care data and the researcher's overall clinical impression from the time treatment was begun, among others. RESULTS: Most of the patients who were evaluated were attended by neurologists (57.4%). The mean time elapsed since Alzheimer's disease was diagnosed was 2.14 +/- 1.68 years. After approximately one year's treatment with rivastigmine solution, the mean score on the Folstein minimental test (MMSE) fell by 0.48 points. CONCLUSIONS: Rivastigmine solution represents a convenient means of administration for patients with moderate and moderately advanced phases of ATD; their cognitive performance is significantly improved with a reduction in the side effects due to a slower and more progressive adjustment of the initial dosage.

[Treatment pattern of Alzheimer's disease with cholinesterase inhibitors (TRAIN study)]. / Patrón de tratamiento de la enfermedad de Alzheimer con inhibidores colinesterásicos (estudio TRAIN).

AIMS: To describe the relation between the level of cognitive impairment in Alzheimer's disease and the use of cholinesterase inhibitors (ChEIs) in neurology, geriatric and psychiatric units, and to establish the clinical profile of these patients. PATIENTS AND METHODS: An epidemiological, multi-centre, cross-sectional study was conducted. Subjects included in the study were consecutive outpatients diagnosed with Alzheimer's disease, in accordance with the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, and who had been treated with rivastigmine, donepezil or galantamine, either on its own or in association with memantine in the last six months. The recruitment period lasted three months. In a single visit, researchers determined the medication that was used, the dose, the mini-mental test, the overall clinical impression-overall improvement and the overall clinical impression-severity of the disease. A total of 1940 patients were selected from neurology, psychiatric and geriatric services all over the country. Possible differences in the habits of different specialists as regards prescribing were analysed, together with the relation between cognitive impairment and the type of medication employed. RESULTS: The mean age of the patients was 77 +/- 6.6 years, 62% of whom were females; the mean score on the mini-mental test was 17.4 +/- 5.5. The mini-mental score was similar in patients treated with rivastigmine (18.02 +/- 5.23), donepezil (17.08 +/- 5.54) or galantamine (17.34 +/- 5.38). In patients who were treated with memantine in association with a ChEI, the mini-mental score was significantly lower (11.44 +/- 5.68) (p < 0.0001). The doses of the different ChEIs used by the specialists were similar. A higher percentage of patients had maximum doses of donepezil (81%) than in the cases of rivastigmine (43%) and galantamine (67%). CONCLUSIONS: The different specialists involved (neurologists, geriatricians and psychiatrists) displayed similar habits regarding the utilisation of ChEIs to treat Alzheimer's disease. There was no relation between the degree of impairment and the drug chosen, except in the case of memantine.

[A comparative study of the effectiveness and tolerability of a procedure involving slow dose-escalation of rivastigmine in patients with mild or moderate Alzheimer-type dementia: the SCALEX study]. / Estudio comparativo de la efectividad y tolerabilidad de un procedimiento de escalado lento de dosis de rivastigmina en pacientes con demencia tipo Alzheimer leve o moderada: estudio SCALEX.

AIMS: To determine and to compare the tolerability and effectiveness of a slow escalation of the dose of rivastigmine in patients with Alzheimer's disease with respect to using it with a faster escalation. PATIENTS AND METHODS: We conducted a multi-centre, naturalistic, open-label, randomised trial with 429 hospital outpatients diagnosed with Alzheimer-type dementia (according to DSM-IV and NINCDS-ADRA criteria) and in whom treatment with rivastigmine was clinically indicated. Two study groups were established: slow escalation and fast escalation (in accordance with usual clinical practice); effectiveness and tolerability variables were analysed in the two groups, as was the proportion of patients who reached therapeutic doses (> 6 mg/day). The scores obtained on the CGI, MMSE, NPI and Barthel index scales were analysed, together with adverse events and reactions concerning spontaneous communication, and scores on the UKU scale. RESULTS: The slow escalation group displayed slightly higher percentages of sub-therapeutic anticipated interruptions than the fast escalation group (chi-square test; p < 0.05). On comparing the two treatment groups, no statistically significant differences were observed for the evolution of the scores on the different scales of effectiveness; no statistically significant differences were found between the two groups in the safety and tolerability analyses (chi-square test, exact test; p > 0.05) for most of the parameters that were studied (adverse reactions in spontaneous communication and the modified UKU scale). CONCLUSION: Slow escalation of the dose of rivastigmine did not display greater effectiveness or tolerability in comparison to an escalation applied in accordance with usual clinical practice.

Patrón de tratamiento de la enfermedad de Alzheimer con inhibidores colinesterásicos (estudio TRAIN) / Treatment pattern of alzheimer’s disease with cholinesterase inhibitors (train study)

Describir la relación entre el nivel de deterioro cognitivo en la enfermedad de Alzheimer y el uso de inhibidores colinesterásicos (IChE) en las consultas de neurología, geriatría y psiquiatría, y caracterizar el perfil clínico de estos pacientes. Pacientes y métodos. Estudio epidemiológico, multicéntrico y transversal. Se incluyeron pacientes consecutivos de consultas externas con diagnóstico de enfermedad de Alzheimer según criterios del Manual diagnóstico y estadístico de lostrastornos mentales, cuarta edición, en tratamiento con rivastigmina, donepecilo o galantamina, solo o asociado a memantina, en los últimos seis meses. El período de reclutamiento duró tres meses. En una visita única se determinó el fármaco utilizado, dosis, test minimental, impresión clínica global-mejoría global e impresión clínica global-gravedad de la enfermedad.Se seleccionaron 1.940 pacientes de consultas de neurología, psiquiatría y geriatría de todo el país. Se analizaron posibles diferencias en los hábitos de prescripción entre los diferentes especialistas, y la relación entre deterioro cognitivo y tipo de fármacoutilizado. Resultados. La edad media de los pacientes era de 77 ± 6,6 años, un 62% mujeres, con una media en el test minimental de 17,4 ± 5,5. El minimental era similar en los pacientes tratados con rivastigmina (18,02 ± 5,23), donepecilo (17,08 ± 5,54) o galantamina (17,34 ± 5,38). En los pacientes tratados con memantina asociada a un IChE, el minimental era significativamente inferior (11,44 ± 5,68) (p < 0,0001). Las dosis de los diferentes IChE utilizadas por los especialistas fueronsimilares. Un mayor porcentaje de pacientes tenía dosis máximas de donepecilo (81%) frente a rivastigmina (43%) y galantamina (67%). Conclusiones. Los hábitos de utilización de IChE en la enfermedad de Alzheimer son similares entre los diferentes especialistas implicados (neurólogos, geriatras, psiquiatras). No había relación entre el grado de deterioro y el fármaco elegido, excepto en el caso de la memantina

To describe the relation between the level of cognitive impairment in Alzheimer’s disease and the use ofcholinesterase inhibitors (ChEIs) in neurology, geriatric and psychiatric units, and to establish the clinical profile of these patients. Patients and methods. An epidemiological, multi-centre, cross-sectional study was conducted. Subjects included inthe study were consecutive outpatients diagnosed with Alzheimer’s disease, in accordance with the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, and who had been treated with rivastigmine, donepezil or galantamine,either on its own or in association with memantine in the last six months. The recruitment period lasted three months. In a single visit, researchers determined the medication that was used, the dose, the mini-mental test, the overall clinicalimpression-overall improvement and the overall clinical impression-severity of the disease. A total of 1940 patients were selected from neurology, psychiatric and geriatric services all over the country. Possible differences in the habits of differentspecialists as regards prescribing were analysed, together with the relation between cognitive impairment and the type of medication employed. Results. The mean age of the patients was 77 ± 6.6 years, 62% of whom were females; the mean score on the mini-mental test was 17.4 ± 5.5. The mini-mental score was similar in patients treated with rivastigmine (18.02 ± 5.23),donepezil (17.08 ± 5.54) or galantamine (17.34 ± 5.38). In patients who were treated with memantine in association with a ChEI, the mini-mental score was significantly lower (11.44 ± 5.68) (p < 0.0001). The doses of the different ChEIs used by thespecialists were similar. A higher percentage of patients had maximum doses of donepezil (81%) than in the cases of rivastigmine (43%) and galantamine (67%). Conclusions. The different specialists involved (neurologists, geriatricians andpsychiatrists) displayed similar habits regarding the utilisation of ChEIs to treat Alzheimer’s disease. There was no relation between the degree of impairment and the drug chosen, except in the case of memantine