ID

36789

Descrizione

The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia; ODM derived from: https://clinicaltrials.gov/show/NCT02415062

collegamento

https://clinicaltrials.gov/show/NCT02415062

Keywords

  1. 08/06/19 08/06/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

8 giugno 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Parkinson's Disease NCT02415062

Eligibility Parkinson's Disease NCT02415062

Criteria
Descrizione

Criteria

patients diagnosed as parkinson's disease according to queen brain bank criteria
Descrizione

Parkinson Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0030567
patients who have been diagnosed as dementia after diagnosing parkinson's disease at least 1 year.
Descrizione

Dementia | Status post Parkinson Disease Diagnosed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0030567
UMLS CUI [2,3]
C0011900
patients with hoehn and yahr staging from 2 to 4
Descrizione

Hoehn and Yahr Stage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3639483
patients with mmse score from 10 to 24
Descrizione

Mini-mental state examination

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0451306
patients who have taken donepezil for at least 12 weeks before screening period
Descrizione

donepezil

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0527316
patients whose medications for parkinson's disease have not change for 1 month
Descrizione

Antiparkinson Agents unchanged

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0442739
patients who give informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria :
Descrizione

Exclusion Criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty
Descrizione

Neuropsychiatry Test Unsuccessful | Hearing difficulty | Visual Impairment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0870956
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C1272705
UMLS CUI [2]
C1313969
UMLS CUI [3]
C3665347
patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -patients diagnosed as dementia with lewy body and vascular dementia-
Descrizione

Pharmaceutical Preparations Affecting Cognitive functions | Anticholinergic Agents | Memantine | Dementia | Lewy Body Disease | Dementia, Vascular

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0392335
UMLS CUI [2]
C0242896
UMLS CUI [3]
C0025242
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0752347
UMLS CUI [6]
C0011269
patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders
Descrizione

Neurosyphilis | Craniocerebral Trauma | Encephalitis | Movement Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027927
UMLS CUI [2]
C0018674
UMLS CUI [3]
C0014038
UMLS CUI [4]
C0026650
patients who have psychiatric disease
Descrizione

Mental disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004936
except patients who are stable state under antidepressant or atypical neuroleptics
Descrizione

Exception Stable status Antidepressive Agents | Exception Stable status Atypical antipsychotic

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0003289
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C1276996
patients with child-bearing periods
Descrizione

Childbearing Potential

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
patients who have severe liver or kidney disease necessary for aggressive treatment
Descrizione

Liver disease Severe | Kidney Disease Severe | Patient need for Treatment Radical

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0439807
patients who have gastrointestinal disease needed for treatment
Descrizione

Gastrointestinal Disease Treatment required for

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332121
patients who cannot taken tablet per oral
Descrizione

Lacking Able to swallow Tablets

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
patients who are participated in other clinical trial except observational study
Descrizione

Study Subject Participation Status | Exception Observational Study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1518527

Similar models

Eligibility Parkinson's Disease NCT02415062

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Parkinson Disease
Item
patients diagnosed as parkinson's disease according to queen brain bank criteria
boolean
C0030567 (UMLS CUI [1])
Dementia | Status post Parkinson Disease Diagnosed
Item
patients who have been diagnosed as dementia after diagnosing parkinson's disease at least 1 year.
boolean
C0497327 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
C0011900 (UMLS CUI [2,3])
Hoehn and Yahr Stage
Item
patients with hoehn and yahr staging from 2 to 4
boolean
C3639483 (UMLS CUI [1])
Mini-mental state examination
Item
patients with mmse score from 10 to 24
boolean
C0451306 (UMLS CUI [1])
donepezil
Item
patients who have taken donepezil for at least 12 weeks before screening period
boolean
C0527316 (UMLS CUI [1])
Antiparkinson Agents unchanged
Item
patients whose medications for parkinson's disease have not change for 1 month
boolean
C0003405 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Informed Consent
Item
patients who give informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
Neuropsychiatry Test Unsuccessful | Hearing difficulty | Visual Impairment
Item
patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty
boolean
C0870956 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C1313969 (UMLS CUI [2])
C3665347 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Cognitive functions | Anticholinergic Agents | Memantine | Dementia | Lewy Body Disease | Dementia, Vascular
Item
patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -patients diagnosed as dementia with lewy body and vascular dementia-
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0392335 (UMLS CUI [1,3])
C0242896 (UMLS CUI [2])
C0025242 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0752347 (UMLS CUI [5])
C0011269 (UMLS CUI [6])
Neurosyphilis | Craniocerebral Trauma | Encephalitis | Movement Disorders
Item
patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders
boolean
C0027927 (UMLS CUI [1])
C0018674 (UMLS CUI [2])
C0014038 (UMLS CUI [3])
C0026650 (UMLS CUI [4])
Mental disorders
Item
patients who have psychiatric disease
boolean
C0004936 (UMLS CUI [1])
Exception Stable status Antidepressive Agents | Exception Stable status Atypical antipsychotic
Item
except patients who are stable state under antidepressant or atypical neuroleptics
boolean
C1705847 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003289 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1276996 (UMLS CUI [2,3])
Childbearing Potential
Item
patients with child-bearing periods
boolean
C3831118 (UMLS CUI [1])
Liver disease Severe | Kidney Disease Severe | Patient need for Treatment Radical
Item
patients who have severe liver or kidney disease necessary for aggressive treatment
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0439807 (UMLS CUI [3,3])
Gastrointestinal Disease Treatment required for
Item
patients who have gastrointestinal disease needed for treatment
boolean
C0017178 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Lacking Able to swallow Tablets
Item
patients who cannot taken tablet per oral
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Study Subject Participation Status | Exception Observational Study
Item
patients who are participated in other clinical trial except observational study
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1518527 (UMLS CUI [2,2])

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