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 mars 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
260
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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Nanchang, Kina
- The Second Affiliated Hospital to Nanchang University
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Nanjing Jiangsu, Kina
- Nanjing Brain Hospital
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Tianjin, Kina
- Tianjin People's Hospital
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Tianjin, Kina
- Tianjin Anding Hospital
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Beijing
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Beijing, Beijing, Kina
- Chinese PLA General Hospital
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Beijing, Beijing, Kina
- Beijing Hospital
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Beijing, Beijing, Kina
- Xuanwu Hospital Capital Medical University
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Beijing, Beijing, Kina
- Beijing Huilongguan Hospital
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Beijing, Beijing, Kina
- Beijing Anding Hospital
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Chongqing
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Chongqing, Chongqing, Kina
- The First Affiliated Hospital of Chongqing Medical University
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Chongqing, Chongqing, Kina
- The Second Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Kina
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, Kina
- Guangzhou Brain Hospital
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Guangxi
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Nanning, Guangxi, Kina
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Hubei
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Wuhan, Hubei, Kina
- Tongji Hospital, Tongji Medical College of HUST
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Wuhan, Hubei, Kina
- Union Hospital, Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina
- The Third XIANGYA Hospital of Central South University
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Yueyang, Hunan, Kina
- The First People's Hospital of Yueyang
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Shandong
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Jinan, Shandong, Kina
- Qilu Hospital of Shandong University
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Jinan, Shandong, Kina
- The Second Hospital of Shandong University
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Qingdao, Shandong, Kina
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai, Shanghai, Kina
- Shanghai Ruijin Hospital
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Shanghai, Shanghai, Kina
- Shanghai Changzheng Hospital
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Shanghai, Shanghai, Kina
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Shanghai, Kina
- Hushan Hospital affliated to Fudan University
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Shanxi
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Xi'An, Shanxi, Kina
- Tangdu Hospital, The Fourth Military Medical University
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Xi'An, Shanxi, Kina
- Xi'an Mental Health Center
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Xi'An, Shanxi, Kina
- Xijing Hospital, The Fourth Military Medical University
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Sichuan
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Chengdu, Sichuan, Kina
- West China Hospital, Sichuan University
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Chengdu, Sichuan, Kina
- Sichuan Provincial People's Hospital
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Yunnan
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Kunming, Yunnan, Kina
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, Kina
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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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 till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
|---|---|
|
Experimentell: 1
|
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.
|
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Placebo-jämförare: 2
|
Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change in the total Severe Impairment Battery (SIB) score at Week 24
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Naoki Kubota, Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
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 (Faktisk)
1 september 2011
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 september 2014
Studieregistreringsdatum
Först inskickad
26 juli 2011
Först inskickad som uppfyllde QC-kriterierna
26 juli 2011
Första postat (Uppskatta)
27 juli 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
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
- Kolinerga medel
- Enzyminhibitorer
- Nootropa medel
- Kolinesterashämmare
- Donepezil
Andra studie-ID-nummer
- E2020-C086-339
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 .