A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
25 de agosto de 2010 actualizado por: Forest Laboratories
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options.
A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver.
The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.
Tipo de estudio
Intervencionista
Inscripción (Actual)
677
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Buenos Aires, Argentina, 1419HDN
- Forest Investigative Site 102
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Buenos Aires, Argentina, C1062ABF
- Forest Investigative Site 118
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Buenos Aires, Argentina, C1117ABE
- Forest Investigative Site 109
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Buenos Aires, Argentina, C1122AAJ
- Forest Investigative Site 104
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Buenos Aires, Argentina, C1126AAB
- Forest Investigative Site 108
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Buenos Aires, Argentina, C1181ACH
- Forest Investigative Site 114
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Buenos Aires, Argentina, C1209AAB
- Forest Investigative Site 106
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Buenos Aires, Argentina, C1405CNF
- Forest Investigative Site 119
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Buenos Aires, Argentina, C1413FWO
- Forest Investigative Site 122
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Buenos Aires, Argentina, C1419AHN
- Forest Investigative Site 107
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Buenos Aires, Argentina, C1425AGP
- Forest Investigative Site 111
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Buenos Aires, Argentina, C1425BPK
- Forest Investigative Site 121
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Buenos Aires, Argentina, C1428AQK
- Forest Investigative Site 115
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Buenos Aires, Argentina, C1428AQK
- Forest Investigative Site 116
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Cordoba, Argentina, X5000ALB
- Forest Investigative Site 112
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Cordoba, Argentina, X5004AOA
- Forest Investigative Site 124
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Mendoza, Argentina, M5500HYF
- Forest Investigative Site 110
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Mendoza, Argentina, M5504FMI
- Forest Investigative Site 125
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Santa Fe, Argentina, S3000FWO
- Forest Investigative Site 120
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Buenos Aires
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Banfield, Buenos Aires, Argentina, B1828CKR
- Forest Investigative Site 103
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La Plata, Buenos Aires, Argentina, B1900AVG
- Forest Investigative Site 105
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Lanus, Buenos Aires, Argentina, C1824IBR
- Forest Investigative Site 123
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSV
- Forest Investigative Site 113
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Antofagasta, Chile
- Forest Investigative Site 302
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Santiago, Chile
- Forest Investigative Site 304
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Santiago, Chile
- Forest Investigative Site 312
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Valdivia, Chile
- Forest Investigative Site 306
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Elqui
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Coquimbo, Elqui, Chile
- Forest Investigative Site 308
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Santiago
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Las Condes, Santiago, Chile
- Forest Investigative Site 301
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Las Condes, Santiago, Chile
- Forest Investigative Site 309
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Providencia, Santiago, Chile
- Forest Investigative Site 303
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Providencia, Santiago, Chile
- Forest Investigative Site 310
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Recoleta, Santiago, Chile
- Forest Investigative Site 313
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San Ramon, Santiago, Chile
- Forest Investigative Site 305
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
- Forest Investigative Site 010
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California
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Costa Mesa, California, Estados Unidos, 92626
- Forest Investigative Site 062
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Fresno, California, Estados Unidos, 93720
- Forest Investigative Site 050
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San Francisco, California, Estados Unidos, 94118
- Forest Investigative Site 024
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Santa Ana, California, Estados Unidos, 92705
- Forest Investigative Site 071
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- Forest Investigative Site 002
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Forest Investigative Site 021
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Boynton Beach, Florida, Estados Unidos, 33426
- Forest Investigative Site 052
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Delray Beach, Florida, Estados Unidos, 33445
- Forest Investigative Site 070
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Fort Myers, Florida, Estados Unidos, 33912
- Forest Investigative Site 065
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Hallandale Beach, Florida, Estados Unidos, 33009
- Forest Investigative Site 043
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Hallandale Beach, Florida, Estados Unidos, 33009
- Forest Investigative Site 044
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Miami, Florida, Estados Unidos, 33137
- Forest Investigative Site 001
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North Miami, Florida, Estados Unidos, 33161
- Forest Investigative Site 034
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Orlando, Florida, Estados Unidos, 32806
- Forest Investigative Site 068
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Palm Beach Gardens, Florida, Estados Unidos, 33410
- Forest Investigative Site 038
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Saint Petersburg, Florida, Estados Unidos, 33709
- Forest Investigative Site 008
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Tampa, Florida, Estados Unidos, 33617
- Forest Investigative Site 028
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Georgia
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Snellville, Georgia, Estados Unidos, 30078
- Forest Investigative Site 009
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Illinois
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Joliet, Illinois, Estados Unidos, 60435
- Forest Investigative Site 069
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Michigan
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Kalamazoo, Michigan, Estados Unidos, 49048
- Forest Investigative Site 045
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Missouri
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Saint Loius, Missouri, Estados Unidos, 63104
- Forest Investigative Site 014
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New Jersey
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Long Branch, New Jersey, Estados Unidos, 07742
- Forest Investigative Site 064
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Morristown, New Jersey, Estados Unidos, 07960
- Forest Investigative Site 011
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New Brunswick, New Jersey, Estados Unidos, 08903
- Forest Investigative Site 003
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New York
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Albany, New York, Estados Unidos, 12205
- Forest Investigative Site 048
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Buffalo, New York, Estados Unidos, 14215
- Forest Investigative Site 006
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White Plains, New York, Estados Unidos, 10605
- Forest Investigative Site 004
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Ohio
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Centerville, Ohio, Estados Unidos, 45459
- Forest Investigative Site 027
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Toledo, Ohio, Estados Unidos, 43623
- Forest Investigative Site 012
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Forest Investigative Site 020
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Pennsylvania
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Greensburg, Pennsylvania, Estados Unidos, 15601
- Forest Investigative Site 032
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Jenkintown, Pennsylvania, Estados Unidos, 19046
- Forest Investigative Site 018
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
- Forest Investigative Site 067
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Texas
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Austin, Texas, Estados Unidos, 78757
- Forest Investigative Site 041
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San Antonio, Texas, Estados Unidos, 78229
- Forest Investigative Site 017
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Virginia
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Richmond, Virginia, Estados Unidos, 23229
- Forest Investigative Site 013
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Forest Investigative Site 026
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Aguascalientes, México, 20230
- Forest Investigative Site 206
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San Luis Potosi, México, 78090
- Forest Investigative Site 210
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Coahuila
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Saltillo, Coahuila, México, 25000
- Forest Investigative Site 212
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Federal District
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Mexico City, Federal District, México, 14000
- Forest Investigative Site 202
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Mexico City, Federal District, México, 14050
- Forest Investigative Site 207
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Guanajuato
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Leon, Guanajuato, México, 37000
- Forest Investigative Site 211
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Jalisco
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Guadalajara, Jalisco, México, 44610
- Forest Investigative Site 205
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Zapopan, Jalisco, México, 45200
- Forest Investigative Site 203
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Nuevo Leon
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Monterrey, Nuevo Leon, México, 44610
- Forest Investigative Site 208
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Monterrey, Nuevo Leon, México, 64710
- Forest Investigative Site 204
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Sinaloa
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Culiacan, Sinaloa, México, 80400
- Forest Investigative Site 213
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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
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Ambulatory patients aged >/= 50 years
- Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
- Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
- Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.
Exclusion Criteria:
- Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
- Patients who have taken memantine within one month of Screening (Visit 1)
- Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
- Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
- Patients who are receiving therapy with more than one AChEI.
- Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
- Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
- Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
- Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
- Patients who had dementia that was complicated by other organic disease
- Patients who had dementia complicated by the presence of predominant delusions
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
Oral administration, once daily.
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Matching placebo oral administration once daily.
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Comparador activo: Memantine ER
28mg, once daily.
Oral administration for 24 weeks.
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28mg(7mg capsules) once daily and oral administration for 24 weeks.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Periodo de tiempo: Baseline to week 24
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The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention.
The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary.
The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result).
The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
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Baseline to week 24
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Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
Periodo de tiempo: Week 24
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The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral.
A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver.
The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
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Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
Periodo de tiempo: Baseline to week 24
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The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia.
Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory.
The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks.
Response range is 0 (total disability) to 54 (total independence).
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Baseline to week 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Stephen M Graham, PhD, Forest Laboratories
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 junio de 2005
Finalización primaria (Actual)
1 de octubre de 2007
Finalización del estudio (Actual)
1 de enero de 2008
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2006
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2006
Publicado por primera vez (Estimar)
5 de mayo de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de septiembre de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2010
Última verificación
1 de agosto de 2010
Más información
Términos relacionados con este estudio
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
- Antagonistas de aminoácidos excitatorios
- Agentes de aminoácidos excitatorios
- Agentes de dopamina
- Agentes antiparkinsonianos
- Agentes contra la discinesia
- Memantina
Otros números de identificación del estudio
- MEM-MD-50
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. .