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- Ensayo clínico NCT00253214
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release Formulation
19 de mayo de 2011 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety and effectiveness of a once daily controlled-release form of galantamine (a drug for treating dementia) versus placebo in the treatment of patients with Alzheimer's disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought.
The most common type of dementia is Alzheimer's disease.
Over time, patients with Alzheimer's disease may lose the ability to perform daily tasks related to personal care (for example, bathing, dressing, and eating) and may be unable to handle money or travel to familiar places.
Previous clinical trials have shown that a twice-daily dose of galantamine (18 - 32 mg/day) improved symptoms of Alzheimer's disease.
This multicenter, double-blind, placebo-controlled study evaluates the safety and effectiveness of a controlled-release form of galantamine in patients with Alzheimer's disease.
All patients receive placebo during the first month of the study.
Patients then receive controlled-release galantamine (8 - 24 mg once daily), or immediate-release galantamine (4 - 12 mg twice daily) or placebo for 6 months.
The dose of galantamine starts at 8 mg/day and may be increased up to 24 mg/day, if needed.
The dose may be adjusted up or down during the first 12 weeks of double-blind treatment based upon effectiveness and tolerability.
Patients continue to receive the dose they are taking at the end of 12 weeks for the remainder of the study.
The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores.
Additional measures of effectiveness include the change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and the Neuropsychiatric Inventory (NPI) scores.
Safety evaluations (incidence of adverse events, electrocardiograms (ECGs), physical examinations, laboratory tests) are performed throughout the study.
Patients who complete the double-blind portion of the study have the opportunity to receive galantamine in an open-label follow-up study.
Patients may also participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies.
The study hypothesis is that treatment with controlled-release galantamine is effective in improving the symptoms of Alzheimer's disease and is well tolerated.
Controlled-release galantamine 8 - 24 mg by mouth once daily, or immediate-release galantamine 4 - 12 mg by mouth twice daily, or placebo.
Dosing starts at 8 mg/day and may be increased up to 24 mg/day, if needed.
The study duration is 6 months.
Tipo de estudio
Intervencionista
Inscripción (Actual)
973
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Outpatients with a diagnosis of mild-to-moderate Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (including patients living in residential homes for the elderly or day patients)
- have a Mini-Mental Status Examination (MMSE) score of 10 - 24, and a score of at least 18 on the cognitive portion of the Alzheimer's Disease Assessment scale (ADAS-cog-11) with an onset between ages 40 and 90
- history of at least a 6 months of gradual and progressive cognitive decline
- have a consistent informant to accompany the patient on scheduled visits
Exclusion Criteria:
- Neurogenerative disorders such as Parkinson's disease
- cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation or a brain tumor
- dementia caused by small strokes or cerebrovascular disease
- having epilepsy, significant psychiatric disease, active peptic ulcer, clinically significant liver, kidney or lung disorders, or heart disease
- females of child bearing potential without adequate contraception
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
Change from baseline to end of treatment for controlled release group in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
|
Medidas de resultado secundarias
Medida de resultado |
---|
Change from baseline in ADAS-cog/13, /10, /mem scores, NPI, and ADCS/ADL; safety and tolerability of controlled-release formulation; difference in effects between the controlled-release and immediate-release formulations
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2001
Finalización del estudio (Actual)
1 de julio de 2002
Fechas de registro del estudio
Enviado por primera vez
10 de noviembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
10 de noviembre de 2005
Publicado por primera vez (Estimar)
15 de noviembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de mayo de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2011
Última verificación
1 de noviembre de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos neurocognitivos
- Enfermedades neurodegenerativas
- Tauopatías
- Demencia
- Enfermedad de Alzheimer
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Inhibidores de enzimas
- Agentes nootrópicos
- Inhibidores de la colinesterasa
- Parasimpaticomiméticos
- Galantamina
Otros números de identificación del estudio
- CR006037
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .