A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
25 agosto 2010 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
677
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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
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Santiago, Chile
- Forest Investigative Site 304
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Santiago, Chile
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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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Aguascalientes, Messico, 20230
- Forest Investigative Site 206
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San Luis Potosi, Messico, 78090
- Forest Investigative Site 210
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Coahuila
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Saltillo, Coahuila, Messico, 25000
- Forest Investigative Site 212
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Federal District
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Mexico City, Federal District, Messico, 14000
- Forest Investigative Site 202
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Mexico City, Federal District, Messico, 14050
- Forest Investigative Site 207
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Guanajuato
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Leon, Guanajuato, Messico, 37000
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Jalisco
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Guadalajara, Jalisco, Messico, 44610
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Zapopan, Jalisco, Messico, 45200
- Forest Investigative Site 203
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Nuevo Leon
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Monterrey, Nuevo Leon, Messico, 44610
- Forest Investigative Site 208
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Monterrey, Nuevo Leon, Messico, 64710
- Forest Investigative Site 204
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Sinaloa
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Culiacan, Sinaloa, Messico, 80400
- Forest Investigative Site 213
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Arizona
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Phoenix, Arizona, Stati Uniti, 85004
- Forest Investigative Site 010
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California
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Costa Mesa, California, Stati Uniti, 92626
- Forest Investigative Site 062
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Fresno, California, Stati Uniti, 93720
- Forest Investigative Site 050
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San Francisco, California, Stati Uniti, 94118
- Forest Investigative Site 024
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Santa Ana, California, Stati Uniti, 92705
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Colorado
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Denver, Colorado, Stati Uniti, 80262
- Forest Investigative Site 002
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Florida
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Boca Raton, Florida, Stati Uniti, 33486
- Forest Investigative Site 021
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Boynton Beach, Florida, Stati Uniti, 33426
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Delray Beach, Florida, Stati Uniti, 33445
- Forest Investigative Site 070
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Fort Myers, Florida, Stati Uniti, 33912
- Forest Investigative Site 065
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Hallandale Beach, Florida, Stati Uniti, 33009
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Hallandale Beach, Florida, Stati Uniti, 33009
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Miami, Florida, Stati Uniti, 33137
- Forest Investigative Site 001
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North Miami, Florida, Stati Uniti, 33161
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Orlando, Florida, Stati Uniti, 32806
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Palm Beach Gardens, Florida, Stati Uniti, 33410
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Saint Petersburg, Florida, Stati Uniti, 33709
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Tampa, Florida, Stati Uniti, 33617
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Georgia
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Snellville, Georgia, Stati Uniti, 30078
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Illinois
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Joliet, Illinois, Stati Uniti, 60435
- Forest Investigative Site 069
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Michigan
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Kalamazoo, Michigan, Stati Uniti, 49048
- Forest Investigative Site 045
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Missouri
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Saint Loius, Missouri, Stati Uniti, 63104
- Forest Investigative Site 014
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New Jersey
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Long Branch, New Jersey, Stati Uniti, 07742
- Forest Investigative Site 064
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Morristown, New Jersey, Stati Uniti, 07960
- Forest Investigative Site 011
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New Brunswick, New Jersey, Stati Uniti, 08903
- Forest Investigative Site 003
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New York
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Albany, New York, Stati Uniti, 12205
- Forest Investigative Site 048
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Buffalo, New York, Stati Uniti, 14215
- Forest Investigative Site 006
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White Plains, New York, Stati Uniti, 10605
- Forest Investigative Site 004
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Ohio
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Centerville, Ohio, Stati Uniti, 45459
- Forest Investigative Site 027
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Toledo, Ohio, Stati Uniti, 43623
- Forest Investigative Site 012
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Oregon
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Portland, Oregon, Stati Uniti, 97210
- Forest Investigative Site 020
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Pennsylvania
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Greensburg, Pennsylvania, Stati Uniti, 15601
- Forest Investigative Site 032
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Jenkintown, Pennsylvania, Stati Uniti, 19046
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Rhode Island
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East Providence, Rhode Island, Stati Uniti, 02914
- Forest Investigative Site 067
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Texas
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Austin, Texas, Stati Uniti, 78757
- Forest Investigative Site 041
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San Antonio, Texas, Stati Uniti, 78229
- Forest Investigative Site 017
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Virginia
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Richmond, Virginia, Stati Uniti, 23229
- Forest Investigative Site 013
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Washington
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Tacoma, Washington, Stati Uniti, 98405
- Forest Investigative Site 026
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
50 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
Oral administration, once daily.
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Matching placebo oral administration once daily.
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Stephen M Graham, PhD, Forest Laboratories
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2005
Completamento primario (Effettivo)
1 ottobre 2007
Completamento dello studio (Effettivo)
1 gennaio 2008
Date di iscrizione allo studio
Primo inviato
3 maggio 2006
Primo inviato che soddisfa i criteri di controllo qualità
4 maggio 2006
Primo Inserito (Stima)
5 maggio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 settembre 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 agosto 2010
Ultimo verificato
1 agosto 2010
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disturbi neurocognitivi
- Malattie Neurodegenerative
- Tauopatie
- Demenza
- Malattia di Alzheimer
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Antagonisti degli aminoacidi eccitatori
- Agenti di aminoacidi eccitatori
- Agenti dopaminergici
- Agenti antiparkinson
- Agenti anti-discinesia
- Memantina
Altri numeri di identificazione dello studio
- MEM-MD-50
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .