- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01276353
A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
5. august 2014 opdateret af: Eisai Inc.
A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Akita, Japan
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Fukuoka, Japan
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Saitama, Japan
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Fukuoka
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Kitakyushu, Fukuoka, Japan
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Gifu
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Mizunami, Gifu, Japan
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Kanagawa
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Yokosuka, Kanagawa, Japan
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Niigata
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Sanjo, Niigata, Japan
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Okayama
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Kurashiki, Okayama, Japan
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Shizuoka
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Fuji, Shizuoka, Japan
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Tokyo
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Hachioji, Tokyo, Japan
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Kodaira, Tokyo, Japan
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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
- Diagnostic evidence of probable Alzheimer's disease (AD) consistent with the Diagnostic and Statistical Manual for Mental Disorders-version IV (DSM-IV)
- Hachinski Ischemic Score
- Functional Assessment Staging (FAST) scale greater than or equal to 6 at Screening.
- Mini-Mental State Examination (MMSE) score of 1 to 12 at Screening
- Subjects who are on a stable Aricept- dose of 10 mg immediate release (IR), taken as a single, daily dose for 3 months prior to the Screening Visit
- Evidence consistent with Alzheimer's disease (AD) on any cranial image on magnetic resonance imaging (MRI) or computed tomography (CT) scan or etc. obtained within 24 months prior to the Screening Visit. Subjects who have any observations of dementia other than Alzheimer's type after the last image diagnosis should be reconfirmed.
- Age 50 years
- Written informed consent is to have been obtained from the subject (if possible) or from the subject's legal guardian or other representative
Exclusion Criteria
- Subjects with dementia other than Alzheimer's type
- Subjects with significant neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, a history of head injury with loss of consciousness, or a history of brain surgery followed by persistent deficits
- Subjects with allergy to donepezil hydrochloride or piperidine derivatives
- Subjects with a cause of Alzheimer's disease (AD) which is supported by any laboratory tests such as Vitamin B12, folate levels, triiodothyronine, free triiodothyronine, thyroxine, thyroid stimulating hormone (TSH) or serologic test for syphilis
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 |
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Eksperimentel: 1
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Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation.
All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.
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Aktiv komparator: 2
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Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation.
All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Tidsramme: Visit 2 [Day1] and Visit 3 [Day 15]
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Visit 2 [Day1] and Visit 3 [Day 15]
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Tidsramme: Visit 2 [Day1] and Visit 3 [Day 15]
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All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes.
Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject.
Since the analysis population i
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Visit 2 [Day1] and Visit 3 [Day 15]
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Naoki Kubota, Neuroscience Clinical Development Section. JAC PCU. 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
1. januar 2011
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
12. januar 2011
Først indsendt, der opfyldte QC-kriterier
12. januar 2011
Først opslået (Skøn)
13. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurokognitive lidelser
- Neurodegenerative sygdomme
- Tauopatier
- Demens
- Alzheimers sygdom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhæmmere
- Nootropiske midler
- Cholinesterasehæmmere
- Donepezil
Andre undersøgelses-id-numre
- E2020-J081-221
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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