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A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

7. marts 2017 opdateret af: Eisai Limited
The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

260

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Nanchang, Kina
        • The Second Affiliated Hospital to Nanchang University
      • Nanjing Jiangsu, Kina
        • Nanjing Brain Hospital
      • Tianjin, Kina
        • Tianjin People's Hospital
      • Tianjin, Kina
        • Tianjin Anding Hospital
    • Beijing
      • Beijing, Beijing, Kina
        • Chinese PLA General Hospital
      • Beijing, Beijing, Kina
        • Beijing Hospital
      • Beijing, Beijing, Kina
        • Xuanwu Hospital Capital Medical University
      • Beijing, Beijing, Kina
        • Beijing Huilongguan Hospital
      • Beijing, Beijing, Kina
        • Beijing Anding Hospital
    • Chongqing
      • Chongqing, Chongqing, Kina
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, Kina
        • The Second Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, Kina
        • Guangzhou Brain Hospital
    • Guangxi
      • Nanning, Guangxi, Kina
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Hubei
      • Wuhan, Hubei, Kina
        • Tongji Hospital, Tongji Medical College of HUST
      • Wuhan, Hubei, Kina
        • Union Hospital, Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Kina
        • The Third Xiangya Hospital of Central South University
      • Yueyang, Hunan, Kina
        • The First People's Hospital of Yueyang
    • Shandong
      • Jinan, Shandong, Kina
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, Kina
        • The Second Hospital of Shandong University
      • Qingdao, Shandong, Kina
        • The Affiliated Hospital of Medical College Qingdao University
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Shanghai Ruijin Hospital
      • Shanghai, Shanghai, Kina
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, Kina
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, Kina
        • Hushan Hospital affliated to Fudan University
    • Shanxi
      • Xi'An, Shanxi, Kina
        • Tangdu Hospital, The Fourth Military Medical University
      • Xi'An, Shanxi, Kina
        • Xi'an Mental Health Center
      • Xi'An, Shanxi, Kina
        • Xijing Hospital, the Fourth Military Medical University
    • Sichuan
      • Chengdu, Sichuan, Kina
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, Kina
        • Sichuan Provincial People's Hospital
    • Yunnan
      • Kunming, Yunnan, Kina
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
  • Subject age range: male and female subjects 50 to 90 years of age, inclusive
  • Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • MMSE 1 to 12 inclusive, at both Screening and Baseline
  • SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
  • Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

  • Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
  • Evidence of focal disease to account for dementia on any cranial image MRI or CT.
  • Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
  • Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
  • Illiteracy prior to AD
  • Subjects who are unwilling or unable to fulfill the requirements of the study
  • Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
  • Subjects with a poor response (tolerability) to prior exposure to donepezil

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
Eksperimentel: 1
Medicin: E2020
In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
Placebo komparator: 2
Medicin: Placebo
Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in the total Severe Impairment Battery (SIB) score at Week 24
Tidsramme: 24 weeks
All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
Tidsramme: 24 weeks
An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.
24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Eisai Limited

Efterforskere

  • Studieleder: Naoki Kubota, Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.

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 (Faktiske)

1. september 2011

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

26. juli 2011

Først indsendt, der opfyldte QC-kriterier

26. juli 2011

Først opslået (Skøn)

27. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E2020-C086-339

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 .

Kliniske forsøg med E2020

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Sponsorer og samarbejdspartnere

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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