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A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

25. august 2010 oppdatert 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

677

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1419HDN
        • Forest Investigative Site 102
      • Buenos Aires, Argentina, C1062ABF
        • Forest Investigative Site 118
      • Buenos Aires, Argentina, C1117ABE
        • Forest Investigative Site 109
      • Buenos Aires, Argentina, C1122AAJ
        • Forest Investigative Site 104
      • Buenos Aires, Argentina, C1126AAB
        • Forest Investigative Site 108
      • Buenos Aires, Argentina, C1181ACH
        • Forest Investigative Site 114
      • Buenos Aires, Argentina, C1209AAB
        • Forest Investigative Site 106
      • Buenos Aires, Argentina, C1405CNF
        • Forest Investigative Site 119
      • Buenos Aires, Argentina, C1413FWO
        • Forest Investigative Site 122
      • Buenos Aires, Argentina, C1419AHN
        • Forest Investigative Site 107
      • Buenos Aires, Argentina, C1425AGP
        • Forest Investigative Site 111
      • Buenos Aires, Argentina, C1425BPK
        • Forest Investigative Site 121
      • Buenos Aires, Argentina, C1428AQK
        • Forest Investigative Site 115
      • Buenos Aires, Argentina, C1428AQK
        • Forest Investigative Site 116
      • Cordoba, Argentina, X5000ALB
        • Forest Investigative Site 112
      • Cordoba, Argentina, X5004AOA
        • Forest Investigative Site 124
      • Mendoza, Argentina, M5500HYF
        • Forest Investigative Site 110
      • Mendoza, Argentina, M5504FMI
        • Forest Investigative Site 125
      • Santa Fe, Argentina, S3000FWO
        • Forest Investigative Site 120
    • Buenos Aires
      • Banfield, Buenos Aires, Argentina, B1828CKR
        • Forest Investigative Site 103
      • La Plata, Buenos Aires, Argentina, B1900AVG
        • Forest Investigative Site 105
      • Lanus, Buenos Aires, Argentina, C1824IBR
        • Forest Investigative Site 123
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Forest Investigative Site 113
  • Chile
      • Antofagasta, Chile
        • Forest Investigative Site 302
      • Santiago, Chile
        • Forest Investigative Site 304
      • Santiago, Chile
        • Forest Investigative Site 312
      • Valdivia, Chile
        • Forest Investigative Site 306
    • Elqui
      • Coquimbo, Elqui, Chile
        • Forest Investigative Site 308
    • Santiago
      • Las Condes, Santiago, Chile
        • Forest Investigative Site 301
      • Las Condes, Santiago, Chile
        • Forest Investigative Site 309
      • Providencia, Santiago, Chile
        • Forest Investigative Site 303
      • Providencia, Santiago, Chile
        • Forest Investigative Site 310
      • Recoleta, Santiago, Chile
        • Forest Investigative Site 313
      • San Ramon, Santiago, Chile
        • Forest Investigative Site 305
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85004
        • Forest Investigative Site 010
    • California
      • Costa Mesa, California, Forente stater, 92626
        • Forest Investigative Site 062
      • Fresno, California, Forente stater, 93720
        • Forest Investigative Site 050
      • San Francisco, California, Forente stater, 94118
        • Forest Investigative Site 024
      • Santa Ana, California, Forente stater, 92705
        • Forest Investigative Site 071
    • Colorado
      • Denver, Colorado, Forente stater, 80262
        • Forest Investigative Site 002
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Forest Investigative Site 021
      • Boynton Beach, Florida, Forente stater, 33426
        • Forest Investigative Site 052
      • Delray Beach, Florida, Forente stater, 33445
        • Forest Investigative Site 070
      • Fort Myers, Florida, Forente stater, 33912
        • Forest Investigative Site 065
      • Hallandale Beach, Florida, Forente stater, 33009
        • Forest Investigative Site 043
      • Hallandale Beach, Florida, Forente stater, 33009
        • Forest Investigative Site 044
      • Miami, Florida, Forente stater, 33137
        • Forest Investigative Site 001
      • North Miami, Florida, Forente stater, 33161
        • Forest Investigative Site 034
      • Orlando, Florida, Forente stater, 32806
        • Forest Investigative Site 068
      • Palm Beach Gardens, Florida, Forente stater, 33410
        • Forest Investigative Site 038
      • Saint Petersburg, Florida, Forente stater, 33709
        • Forest Investigative Site 008
      • Tampa, Florida, Forente stater, 33617
        • Forest Investigative Site 028
    • Georgia
      • Snellville, Georgia, Forente stater, 30078
        • Forest Investigative Site 009
    • Illinois
      • Joliet, Illinois, Forente stater, 60435
        • Forest Investigative Site 069
    • Michigan
      • Kalamazoo, Michigan, Forente stater, 49048
        • Forest Investigative Site 045
    • Missouri
      • Saint Loius, Missouri, Forente stater, 63104
        • Forest Investigative Site 014
    • New Jersey
      • Long Branch, New Jersey, Forente stater, 07742
        • Forest Investigative Site 064
      • Morristown, New Jersey, Forente stater, 07960
        • Forest Investigative Site 011
      • New Brunswick, New Jersey, Forente stater, 08903
        • Forest Investigative Site 003
    • New York
      • Albany, New York, Forente stater, 12205
        • Forest Investigative Site 048
      • Buffalo, New York, Forente stater, 14215
        • Forest Investigative Site 006
      • White Plains, New York, Forente stater, 10605
        • Forest Investigative Site 004
    • Ohio
      • Centerville, Ohio, Forente stater, 45459
        • Forest Investigative Site 027
      • Toledo, Ohio, Forente stater, 43623
        • Forest Investigative Site 012
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Forest Investigative Site 020
    • Pennsylvania
      • Greensburg, Pennsylvania, Forente stater, 15601
        • Forest Investigative Site 032
      • Jenkintown, Pennsylvania, Forente stater, 19046
        • Forest Investigative Site 018
    • Rhode Island
      • East Providence, Rhode Island, Forente stater, 02914
        • Forest Investigative Site 067
    • Texas
      • Austin, Texas, Forente stater, 78757
        • Forest Investigative Site 041
      • San Antonio, Texas, Forente stater, 78229
        • Forest Investigative Site 017
    • Virginia
      • Richmond, Virginia, Forente stater, 23229
        • Forest Investigative Site 013
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Forest Investigative Site 026
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Forest Investigative Site 206
      • San Luis Potosi, Mexico, 78090
        • Forest Investigative Site 210
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25000
        • Forest Investigative Site 212
    • Federal District
      • Mexico City, Federal District, Mexico, 14000
        • Forest Investigative Site 202
      • Mexico City, Federal District, Mexico, 14050
        • Forest Investigative Site 207
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Forest Investigative Site 211
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44610
        • Forest Investigative Site 205
      • Zapopan, Jalisco, Mexico, 45200
        • Forest Investigative Site 203
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 44610
        • Forest Investigative Site 208
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Forest Investigative Site 204
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80400
        • Forest Investigative Site 213

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Oral administration, once daily.
Legemiddel: Placebo
Matching placebo oral administration once daily.
Aktiv komparator: Memantine ER
28mg, once daily. Oral administration for 24 weeks.
Legemiddel: memantine ER
28mg(7mg capsules) once daily and oral administration for 24 weeks.
Andre navn:
  • Namenda XR

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Tidsramme: Baseline to week 24
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.
Baseline to week 24
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
Tidsramme: Week 24
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."
Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
Tidsramme: Baseline to week 24
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).
Baseline to week 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Forest Laboratories

Etterforskere

  • Studieleder: Stephen M Graham, PhD, Forest Laboratories

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2005

Primær fullføring (Faktiske)

1. oktober 2007

Studiet fullført (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først innsendt

3. mai 2006

Først innsendt som oppfylte QC-kriteriene

4. mai 2006

Først lagt ut (Anslag)

5. mai 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. september 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2010

Sist bekreftet

1. august 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MEM-MD-50

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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