ID

36789

Description

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

Link

https://clinicaltrials.gov/show/NCT02415062

Keywords

Versions (1)
  1. 6/8/19 6/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02415062

English

Eligibility Parkinson's Disease NCT02415062

1 forms  
Criteria
Description

Criteria

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

Parkinson Disease

Data type

boolean

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

Dementia | Status post Parkinson Disease Diagnosed

Data type

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
Description

Hoehn and Yahr Stage

Data type

boolean

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

Mini-mental state examination

Data type

boolean

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

donepezil

Data type

boolean

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

Antiparkinson Agents unchanged

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria :
Description

Exclusion Criteria

Data type

boolean

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

Neuropsychiatry Test Unsuccessful | Hearing difficulty | Visual Impairment

Data type

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-
Description

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

Data type

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
Description

Neurosyphilis | Craniocerebral Trauma | Encephalitis | Movement Disorders

Data type

boolean

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

Mental disorders

Data type

boolean

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

Exception Stable status Antidepressive Agents | Exception Stable status Atypical antipsychotic

Data type

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
Description

Childbearing Potential

Data type

boolean

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

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

Data type

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
Description

Gastrointestinal Disease Treatment required for

Data type

boolean

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

Lacking Able to swallow Tablets

Data type

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
Description

Study Subject Participation Status | Exception Observational Study

Data type

boolean

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

Eligibility Parkinson's Disease NCT02415062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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