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

25. august 2010 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

677

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85004
        • Forest Investigative Site 010
    • California
      • Costa Mesa, California, Forenede Stater, 92626
        • Forest Investigative Site 062
      • Fresno, California, Forenede Stater, 93720
        • Forest Investigative Site 050
      • San Francisco, California, Forenede Stater, 94118
        • Forest Investigative Site 024
      • Santa Ana, California, Forenede Stater, 92705
        • Forest Investigative Site 071
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • Forest Investigative Site 002
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Forest Investigative Site 021
      • Boynton Beach, Florida, Forenede Stater, 33426
        • Forest Investigative Site 052
      • Delray Beach, Florida, Forenede Stater, 33445
        • Forest Investigative Site 070
      • Fort Myers, Florida, Forenede Stater, 33912
        • Forest Investigative Site 065
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • Forest Investigative Site 043
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • Forest Investigative Site 044
      • Miami, Florida, Forenede Stater, 33137
        • Forest Investigative Site 001
      • North Miami, Florida, Forenede Stater, 33161
        • Forest Investigative Site 034
      • Orlando, Florida, Forenede Stater, 32806
        • Forest Investigative Site 068
      • Palm Beach Gardens, Florida, Forenede Stater, 33410
        • Forest Investigative Site 038
      • Saint Petersburg, Florida, Forenede Stater, 33709
        • Forest Investigative Site 008
      • Tampa, Florida, Forenede Stater, 33617
        • Forest Investigative Site 028
    • Georgia
      • Snellville, Georgia, Forenede Stater, 30078
        • Forest Investigative Site 009
    • Illinois
      • Joliet, Illinois, Forenede Stater, 60435
        • Forest Investigative Site 069
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Forest Investigative Site 045
    • Missouri
      • Saint Loius, Missouri, Forenede Stater, 63104
        • Forest Investigative Site 014
    • New Jersey
      • Long Branch, New Jersey, Forenede Stater, 07742
        • Forest Investigative Site 064
      • Morristown, New Jersey, Forenede Stater, 07960
        • Forest Investigative Site 011
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Forest Investigative Site 003
    • New York
      • Albany, New York, Forenede Stater, 12205
        • Forest Investigative Site 048
      • Buffalo, New York, Forenede Stater, 14215
        • Forest Investigative Site 006
      • White Plains, New York, Forenede Stater, 10605
        • Forest Investigative Site 004
    • Ohio
      • Centerville, Ohio, Forenede Stater, 45459
        • Forest Investigative Site 027
      • Toledo, Ohio, Forenede Stater, 43623
        • Forest Investigative Site 012
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Forest Investigative Site 020
    • Pennsylvania
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • Forest Investigative Site 032
      • Jenkintown, Pennsylvania, Forenede Stater, 19046
        • Forest Investigative Site 018
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Forest Investigative Site 067
    • Texas
      • Austin, Texas, Forenede Stater, 78757
        • Forest Investigative Site 041
      • San Antonio, Texas, Forenede Stater, 78229
        • Forest Investigative Site 017
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
        • Forest Investigative Site 013
    • Washington
      • Tacoma, Washington, Forenede 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Forest Laboratories

Efterforskere

  • Studieleder: Stephen M Graham, PhD, Forest Laboratories

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2005

Primær færdiggørelse (Faktiske)

1. oktober 2007

Studieafslutning (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først indsendt

3. maj 2006

Først indsendt, der opfyldte QC-kriterier

4. maj 2006

Først opslået (Skøn)

5. maj 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. september 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2010

Sidst verificeret

1. august 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MEM-MD-50

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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