A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
25 augusti 2010 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
677
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Förenta staterna, 85004
- Forest Investigative Site 010
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California
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Costa Mesa, California, Förenta staterna, 92626
- Forest Investigative Site 062
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Fresno, California, Förenta staterna, 93720
- Forest Investigative Site 050
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San Francisco, California, Förenta staterna, 94118
- Forest Investigative Site 024
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Santa Ana, California, Förenta staterna, 92705
- Forest Investigative Site 071
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Colorado
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Denver, Colorado, Förenta staterna, 80262
- Forest Investigative Site 002
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Florida
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Boca Raton, Florida, Förenta staterna, 33486
- Forest Investigative Site 021
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Boynton Beach, Florida, Förenta staterna, 33426
- Forest Investigative Site 052
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Delray Beach, Florida, Förenta staterna, 33445
- Forest Investigative Site 070
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Fort Myers, Florida, Förenta staterna, 33912
- Forest Investigative Site 065
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Hallandale Beach, Florida, Förenta staterna, 33009
- Forest Investigative Site 043
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Hallandale Beach, Florida, Förenta staterna, 33009
- Forest Investigative Site 044
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Miami, Florida, Förenta staterna, 33137
- Forest Investigative Site 001
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North Miami, Florida, Förenta staterna, 33161
- Forest Investigative Site 034
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Orlando, Florida, Förenta staterna, 32806
- Forest Investigative Site 068
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Palm Beach Gardens, Florida, Förenta staterna, 33410
- Forest Investigative Site 038
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Saint Petersburg, Florida, Förenta staterna, 33709
- Forest Investigative Site 008
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Tampa, Florida, Förenta staterna, 33617
- Forest Investigative Site 028
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Georgia
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Snellville, Georgia, Förenta staterna, 30078
- Forest Investigative Site 009
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Illinois
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Joliet, Illinois, Förenta staterna, 60435
- Forest Investigative Site 069
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Michigan
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Kalamazoo, Michigan, Förenta staterna, 49048
- Forest Investigative Site 045
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Missouri
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Saint Loius, Missouri, Förenta staterna, 63104
- Forest Investigative Site 014
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New Jersey
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Long Branch, New Jersey, Förenta staterna, 07742
- Forest Investigative Site 064
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Morristown, New Jersey, Förenta staterna, 07960
- Forest Investigative Site 011
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New Brunswick, New Jersey, Förenta staterna, 08903
- Forest Investigative Site 003
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New York
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Albany, New York, Förenta staterna, 12205
- Forest Investigative Site 048
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Buffalo, New York, Förenta staterna, 14215
- Forest Investigative Site 006
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White Plains, New York, Förenta staterna, 10605
- Forest Investigative Site 004
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Ohio
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Centerville, Ohio, Förenta staterna, 45459
- Forest Investigative Site 027
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Toledo, Ohio, Förenta staterna, 43623
- Forest Investigative Site 012
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Oregon
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Portland, Oregon, Förenta staterna, 97210
- Forest Investigative Site 020
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Pennsylvania
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Greensburg, Pennsylvania, Förenta staterna, 15601
- Forest Investigative Site 032
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Jenkintown, Pennsylvania, Förenta staterna, 19046
- Forest Investigative Site 018
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Rhode Island
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East Providence, Rhode Island, Förenta staterna, 02914
- Forest Investigative Site 067
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Texas
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Austin, Texas, Förenta staterna, 78757
- Forest Investigative Site 041
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San Antonio, Texas, Förenta staterna, 78229
- Forest Investigative Site 017
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Virginia
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Richmond, Virginia, Förenta staterna, 23229
- Forest Investigative Site 013
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Washington
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Tacoma, Washington, Förenta staterna, 98405
- Forest Investigative Site 026
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Aguascalientes, Mexiko, 20230
- Forest Investigative Site 206
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San Luis Potosi, Mexiko, 78090
- Forest Investigative Site 210
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Coahuila
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Saltillo, Coahuila, Mexiko, 25000
- Forest Investigative Site 212
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Federal District
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Mexico City, Federal District, Mexiko, 14000
- Forest Investigative Site 202
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Mexico City, Federal District, Mexiko, 14050
- Forest Investigative Site 207
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Guanajuato
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Leon, Guanajuato, Mexiko, 37000
- Forest Investigative Site 211
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44610
- Forest Investigative Site 205
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Zapopan, Jalisco, Mexiko, 45200
- Forest Investigative Site 203
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexiko, 44610
- Forest Investigative Site 208
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Monterrey, Nuevo Leon, Mexiko, 64710
- Forest Investigative Site 204
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Sinaloa
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Culiacan, Sinaloa, Mexiko, 80400
- Forest Investigative Site 213
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
Oral administration, once daily.
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Matching placebo oral administration once daily.
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Aktiv komparator: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Stephen M Graham, PhD, Forest Laboratories
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2005
Primärt slutförande (Faktisk)
1 oktober 2007
Avslutad studie (Faktisk)
1 januari 2008
Studieregistreringsdatum
Först inskickad
3 maj 2006
Först inskickad som uppfyllde QC-kriterierna
4 maj 2006
Första postat (Uppskatta)
5 maj 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 september 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2010
Senast verifierad
1 augusti 2010
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neurokognitiva störningar
- Neurodegenerativa sjukdomar
- Tauopatier
- Demens
- Alzheimers sjukdom
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Excitatoriska aminosyraantagonister
- Excitatoriska aminosyror
- Dopaminmedel
- Antiparkinsonmedel
- Medel mot dyskinesi
- Memantin
Andra studie-ID-nummer
- MEM-MD-50
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .