A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
25 août 2010 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
677
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Buenos Aires, Argentine, 1419HDN
- Forest Investigative Site 102
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Buenos Aires, Argentine, C1062ABF
- Forest Investigative Site 118
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Buenos Aires, Argentine, C1117ABE
- Forest Investigative Site 109
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Buenos Aires, Argentine, C1122AAJ
- Forest Investigative Site 104
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Buenos Aires, Argentine, C1126AAB
- Forest Investigative Site 108
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Buenos Aires, Argentine, C1181ACH
- Forest Investigative Site 114
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Buenos Aires, Argentine, C1209AAB
- Forest Investigative Site 106
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Buenos Aires, Argentine, C1405CNF
- Forest Investigative Site 119
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Buenos Aires, Argentine, C1413FWO
- Forest Investigative Site 122
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Buenos Aires, Argentine, C1419AHN
- Forest Investigative Site 107
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Buenos Aires, Argentine, C1425AGP
- Forest Investigative Site 111
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Buenos Aires, Argentine, C1425BPK
- Forest Investigative Site 121
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Buenos Aires, Argentine, C1428AQK
- Forest Investigative Site 115
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Buenos Aires, Argentine, C1428AQK
- Forest Investigative Site 116
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Cordoba, Argentine, X5000ALB
- Forest Investigative Site 112
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Cordoba, Argentine, X5004AOA
- Forest Investigative Site 124
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Mendoza, Argentine, M5500HYF
- Forest Investigative Site 110
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Mendoza, Argentine, M5504FMI
- Forest Investigative Site 125
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Santa Fe, Argentine, S3000FWO
- Forest Investigative Site 120
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Buenos Aires
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Banfield, Buenos Aires, Argentine, B1828CKR
- Forest Investigative Site 103
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La Plata, Buenos Aires, Argentine, B1900AVG
- Forest Investigative Site 105
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Lanus, Buenos Aires, Argentine, C1824IBR
- Forest Investigative Site 123
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Santa Fe
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Rosario, Santa Fe, Argentine, S2000DSV
- Forest Investigative Site 113
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Antofagasta, Chili
- Forest Investigative Site 302
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Santiago, Chili
- Forest Investigative Site 304
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Santiago, Chili
- Forest Investigative Site 312
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Valdivia, Chili
- Forest Investigative Site 306
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Elqui
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Coquimbo, Elqui, Chili
- Forest Investigative Site 308
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Santiago
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Las Condes, Santiago, Chili
- Forest Investigative Site 301
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Las Condes, Santiago, Chili
- Forest Investigative Site 309
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Providencia, Santiago, Chili
- Forest Investigative Site 303
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Providencia, Santiago, Chili
- Forest Investigative Site 310
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Recoleta, Santiago, Chili
- Forest Investigative Site 313
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San Ramon, Santiago, Chili
- Forest Investigative Site 305
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Aguascalientes, Mexique, 20230
- Forest Investigative Site 206
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San Luis Potosi, Mexique, 78090
- Forest Investigative Site 210
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Coahuila
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Saltillo, Coahuila, Mexique, 25000
- Forest Investigative Site 212
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Federal District
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Mexico City, Federal District, Mexique, 14000
- Forest Investigative Site 202
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Mexico City, Federal District, Mexique, 14050
- Forest Investigative Site 207
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Guanajuato
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Leon, Guanajuato, Mexique, 37000
- Forest Investigative Site 211
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Jalisco
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Guadalajara, Jalisco, Mexique, 44610
- Forest Investigative Site 205
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Zapopan, Jalisco, Mexique, 45200
- Forest Investigative Site 203
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexique, 44610
- Forest Investigative Site 208
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Monterrey, Nuevo Leon, Mexique, 64710
- Forest Investigative Site 204
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Sinaloa
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Culiacan, Sinaloa, Mexique, 80400
- Forest Investigative Site 213
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Arizona
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Phoenix, Arizona, États-Unis, 85004
- Forest Investigative Site 010
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California
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Costa Mesa, California, États-Unis, 92626
- Forest Investigative Site 062
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Fresno, California, États-Unis, 93720
- Forest Investigative Site 050
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San Francisco, California, États-Unis, 94118
- Forest Investigative Site 024
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Santa Ana, California, États-Unis, 92705
- Forest Investigative Site 071
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Colorado
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Denver, Colorado, États-Unis, 80262
- Forest Investigative Site 002
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Florida
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Boca Raton, Florida, États-Unis, 33486
- Forest Investigative Site 021
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Boynton Beach, Florida, États-Unis, 33426
- Forest Investigative Site 052
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Delray Beach, Florida, États-Unis, 33445
- Forest Investigative Site 070
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Fort Myers, Florida, États-Unis, 33912
- Forest Investigative Site 065
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Hallandale Beach, Florida, États-Unis, 33009
- Forest Investigative Site 043
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Hallandale Beach, Florida, États-Unis, 33009
- Forest Investigative Site 044
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Miami, Florida, États-Unis, 33137
- Forest Investigative Site 001
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North Miami, Florida, États-Unis, 33161
- Forest Investigative Site 034
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Orlando, Florida, États-Unis, 32806
- Forest Investigative Site 068
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Palm Beach Gardens, Florida, États-Unis, 33410
- Forest Investigative Site 038
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Saint Petersburg, Florida, États-Unis, 33709
- Forest Investigative Site 008
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Tampa, Florida, États-Unis, 33617
- Forest Investigative Site 028
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Georgia
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Snellville, Georgia, États-Unis, 30078
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Illinois
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Joliet, Illinois, États-Unis, 60435
- Forest Investigative Site 069
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Michigan
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Kalamazoo, Michigan, États-Unis, 49048
- Forest Investigative Site 045
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Missouri
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Saint Loius, Missouri, États-Unis, 63104
- Forest Investigative Site 014
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New Jersey
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Long Branch, New Jersey, États-Unis, 07742
- Forest Investigative Site 064
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Morristown, New Jersey, États-Unis, 07960
- Forest Investigative Site 011
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New Brunswick, New Jersey, États-Unis, 08903
- Forest Investigative Site 003
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New York
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Albany, New York, États-Unis, 12205
- Forest Investigative Site 048
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Buffalo, New York, États-Unis, 14215
- Forest Investigative Site 006
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White Plains, New York, États-Unis, 10605
- Forest Investigative Site 004
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Ohio
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Centerville, Ohio, États-Unis, 45459
- Forest Investigative Site 027
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Toledo, Ohio, États-Unis, 43623
- Forest Investigative Site 012
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Oregon
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Portland, Oregon, États-Unis, 97210
- Forest Investigative Site 020
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Pennsylvania
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Greensburg, Pennsylvania, États-Unis, 15601
- Forest Investigative Site 032
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Jenkintown, Pennsylvania, États-Unis, 19046
- Forest Investigative Site 018
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Rhode Island
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East Providence, Rhode Island, États-Unis, 02914
- Forest Investigative Site 067
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Texas
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Austin, Texas, États-Unis, 78757
- Forest Investigative Site 041
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San Antonio, Texas, États-Unis, 78229
- Forest Investigative Site 017
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Virginia
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Richmond, Virginia, États-Unis, 23229
- Forest Investigative Site 013
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Washington
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Tacoma, Washington, États-Unis, 98405
- Forest Investigative Site 026
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
Oral administration, once daily.
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Matching placebo oral administration once daily.
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Comparateur actif: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Stephen M Graham, PhD, Forest Laboratories
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2005
Achèvement primaire (Réel)
1 octobre 2007
Achèvement de l'étude (Réel)
1 janvier 2008
Dates d'inscription aux études
Première soumission
3 mai 2006
Première soumission répondant aux critères de contrôle qualité
4 mai 2006
Première publication (Estimation)
5 mai 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 septembre 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 août 2010
Dernière vérification
1 août 2010
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles neurocognitifs
- Maladies neurodégénératives
- Tauopathies
- Démence
- Maladie d'Alzheimer
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Antagonistes des acides aminés excitateurs
- Agents d'acides aminés excitateurs
- Agents dopaminergiques
- Agents antiparkinsoniens
- Agents anti-dyskinésie
- Mémantine
Autres numéros d'identification d'étude
- MEM-MD-50
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .