ID

13279

Description

Effect of Indomethacin on the Progression of Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00432081

Link

https://clinicaltrials.gov/show/NCT00432081

Keywords

Versions (1)
  1. 1/29/16 1/29/16 -
Uploaded on

January 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00432081

English

Eligibility Alzheimer Disease NCT00432081

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient will satisfy the dsm-iv criteria for dementia of the alzheimer’s type.
Description

dsm-iv criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C1387192
the patient will satisfy the nincds/adrda criteria for the clinical diagnosis of probable alzheimer’s disease (appendix i).
Description

nincds/adrda criteria

Data type

boolean

Alias
UMLS CUI [1]
C2828081
the severity of dementia for each patient will be quantified by a mini-mental state examination (mmse) score between 10 and 26 (both inclusive).
Description

severity of dementia

Data type

boolean

Alias
UMLS CUI [1]
C0451306
the patient is living at home or in a home for the elderly.
Description

residence

Data type

boolean

Alias
UMLS CUI [1]
C0237096
the patient has a responsible caregiver who is able to provide information about the patient’s functional status.
Description

Caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
written informed consent is obtained from the patient or the legally accepted representative.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient satisfies the ninds-airen criteria for probable vascular dementia.
Description

Vascular dementia

Data type

boolean

Alias
UMLS CUI [1]
C0011269
a known exaggerated pharmacological sensitivity or allergy to nsaid’s.
Description

Allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
history of peptic ulceration, gastric surgery or gastrointestinal bleeding.
Description

Gastrointestinal status

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0192398
UMLS CUI [3]
C0017181
current diagnosis of active peptic ulceration.
Description

peptic ulceration

Data type

boolean

Alias
UMLS CUI [1]
C0030920
current diagnosis of severe and unstable cardiovascular disease.
Description

cardiovascular status

Data type

boolean

Alias
UMLS CUI [1]
C0007222
current diagnosis of renal failure.
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0035078
advanced, severe and unstable disease of any type, other than alzheimer’s disease, that may interfere with primary and secondary variable evaluations, including a medical condition which should be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
intake of any of the following concomitant medications: salicylates, coumarin derivatives, ace-inhibitors, loop diuretics.
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0036075
UMLS CUI [2]
C0010207
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0354100
intake of any of the following concomitant medications more than two months immediately prior or during the study: nsaid’s, systemic corticosteroids.
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C3653708
intake of any of the following concomitant medications with a possible effect on cognition: estrogen, deprenyl, vitamin e, neuroleptics, anticholinergics. patients using stable doses of cholinesterase inhibitors were eligible, with the provision that the dose should not be changed during the study. cholinesterase inhibitors could not be initiated during the study.
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3541386
UMLS CUI [2]
C0086130
UMLS CUI [3]
C1142098
UMLS CUI [4]
C0040615
UMLS CUI [5]
C0242896
UMLS CUI [6,1]
C0008429
UMLS CUI [6,2]
C0008429
excessive use of alcohol (more than 5 units per day)
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
the patient is, either alone or with the aid of a caregiver, not able to reliably take the medication.
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
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Similar models

Eligibility Alzheimer Disease NCT00432081

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
dsm-iv criteria
Item
the patient will satisfy the dsm-iv criteria for dementia of the alzheimer’s type.
boolean
C0220952 (UMLS CUI [1,1])
C1387192 (UMLS CUI [1,2])
nincds/adrda criteria
Item
the patient will satisfy the nincds/adrda criteria for the clinical diagnosis of probable alzheimer’s disease (appendix i).
boolean
C2828081 (UMLS CUI [1])
severity of dementia
Item
the severity of dementia for each patient will be quantified by a mini-mental state examination (mmse) score between 10 and 26 (both inclusive).
boolean
C0451306 (UMLS CUI [1])
residence
Item
the patient is living at home or in a home for the elderly.
boolean
C0237096 (UMLS CUI [1])
Caregiver
Item
the patient has a responsible caregiver who is able to provide information about the patient’s functional status.
boolean
C0085537 (UMLS CUI [1])
Informed consent
Item
written informed consent is obtained from the patient or the legally accepted representative.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vascular dementia
Item
the patient satisfies the ninds-airen criteria for probable vascular dementia.
boolean
C0011269 (UMLS CUI [1])
Allergy
Item
a known exaggerated pharmacological sensitivity or allergy to nsaid’s.
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
Gastrointestinal status
Item
history of peptic ulceration, gastric surgery or gastrointestinal bleeding.
boolean
C0030920 (UMLS CUI [1])
C0192398 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
peptic ulceration
Item
current diagnosis of active peptic ulceration.
boolean
C0030920 (UMLS CUI [1])
cardiovascular status
Item
current diagnosis of severe and unstable cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
renal function
Item
current diagnosis of renal failure.
boolean
C0035078 (UMLS CUI [1])
Comorbidity
Item
advanced, severe and unstable disease of any type, other than alzheimer’s disease, that may interfere with primary and secondary variable evaluations, including a medical condition which should be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Pharmacotherapy
Item
intake of any of the following concomitant medications: salicylates, coumarin derivatives, ace-inhibitors, loop diuretics.
boolean
C0036075 (UMLS CUI [1])
C0010207 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0354100 (UMLS CUI [4])
Pharmacotherapy
Item
intake of any of the following concomitant medications more than two months immediately prior or during the study: nsaid’s, systemic corticosteroids.
boolean
C0003211 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Pharmacotherapy
Item
intake of any of the following concomitant medications with a possible effect on cognition: estrogen, deprenyl, vitamin e, neuroleptics, anticholinergics. patients using stable doses of cholinesterase inhibitors were eligible, with the provision that the dose should not be changed during the study. cholinesterase inhibitors could not be initiated during the study.
boolean
C3541386 (UMLS CUI [1])
C0086130 (UMLS CUI [2])
C1142098 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C0242896 (UMLS CUI [5])
C0008429 (UMLS CUI [6,1])
C0008429 (UMLS CUI [6,2])
Alcohol consumption
Item
excessive use of alcohol (more than 5 units per day)
boolean
C0001948 (UMLS CUI [1])
Compliance
Item
the patient is, either alone or with the aid of a caregiver, not able to reliably take the medication.
boolean
C0013216 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
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