KAPAA Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease
Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)
+ Rivastigmine patch (9.5 mg/day)
+ Rivastigmine capsules (6 mg to 12 mg/day)
Enfermedades del Sistema Nervioso Central+3
+ Enfermedad de Alzheimer
+ Demencia
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2007
Fecha en la que se inscribió al primer participante.This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 142 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 60 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score \> 10 and \< 26 * Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study * Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver * Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study. Exclusion Criteria: * A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis) * Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application) * History of allergy to topical products containing vitamin E * Taken any of the following substances prior to randomization: * succinylcholine-type muscle relaxants during the previous 2 weeks * an investigational drug during the previous 4 weeks Other protocol-defined inclusion/exclusion criteria applied to the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación