ID

39032

Description

Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01153607

Link

https://clinicaltrials.gov/show/NCT01153607

Keywords

Versions (1)
  1. 11/22/19 11/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diagnostic Imaging NCT01153607

English

Eligibility Diagnostic Imaging NCT01153607

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all:
Description

All

Data type

boolean

Alias
UMLS CUI [1]
C0444868
males or females aged >/- 50 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
healthy volunteers for brain imaging:
Description

Healthy Volunteers Imaging of brain

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0203860
mini-mental state examination (mmse) score of >/= 28
Description

Mini-mental status exam score (___/30)

Data type

boolean

Alias
UMLS CUI [1]
C2225229
cdr score of zero (0)
Description

Clinical dementia rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451074
patients for brain imaging:
Description

Patients Imaging of brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0203860
patient fulfills diagnostic and statistical manual of mental disorders (dsm-iv) and national institute of neurological and communicative disorders and stroke, alzheimer's disease and related disorders association (nincds-adrda) criteria for probable alzheimer's disease (ad), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
Description

Alzheimer's Disease Probable | Impaired cognition | Memory impairment | Aphasia | Apraxia | Agnosia | Executive dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0033204
UMLS CUI [2]
C0338656
UMLS CUI [3]
C0233794
UMLS CUI [4]
C0003537
UMLS CUI [5]
C0003635
UMLS CUI [6]
C0001816
UMLS CUI [7]
C2748208
patient has mild to moderate dementia with a dementia score of >/= 20 on the mini mental state examination (mmse) / with a clinical dementia rating score of 1 or 2 (cdr)
Description

Mild dementia Mini-mental status exam score (___/30) | Moderate dementia Mini-mental status exam score (___/30) | Mild dementia Clinical dementia rating scale | Moderate dementia Clinical dementia rating scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3494623
UMLS CUI [1,2]
C2225229
UMLS CUI [2,1]
C3494871
UMLS CUI [2,2]
C2225229
UMLS CUI [3,1]
C3494623
UMLS CUI [3,2]
C0451074
UMLS CUI [4,1]
C3494871
UMLS CUI [4,2]
C0451074
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all:
Description

All

Data type

boolean

Alias
UMLS CUI [1]
C0444868
no significant disease or drug use
Description

Disease Significant Absent | Drug use Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0242510
UMLS CUI [2,2]
C0332197
patients for brain imaging:
Description

Patients Imaging of brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0203860
evidence for any other neurological or psychiatric disease
Description

Nervous system disorder Other | Mental disorder Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205394
healthy volunteers for brain imaging:
Description

Healthy Volunteers Imaging of brain

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0203860
family history of alzheimer's disease in a 1st or 2nd degree relative under 75 years of age
Description

Family history of Alzheimer's disease | First Degree Relative | Second Degree Relative | Age

Data type

boolean

Alias
UMLS CUI [1]
C1271045
UMLS CUI [2]
C1517194
UMLS CUI [3]
C1519210
UMLS CUI [4]
C0001779
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Similar models

Eligibility Diagnostic Imaging NCT01153607

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
All
Item
all:
boolean
C0444868 (UMLS CUI [1])
Age
Item
males or females aged >/- 50 years
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Healthy Volunteers Imaging of brain
Item
healthy volunteers for brain imaging:
boolean
C1708335 (UMLS CUI [1,1])
C0203860 (UMLS CUI [1,2])
Mini-mental status exam score (___/30)
Item
mini-mental state examination (mmse) score of >/= 28
boolean
C2225229 (UMLS CUI [1])
Clinical dementia rating scale
Item
cdr score of zero (0)
boolean
C0451074 (UMLS CUI [1])
Patients Imaging of brain
Item
patients for brain imaging:
boolean
C0030705 (UMLS CUI [1,1])
C0203860 (UMLS CUI [1,2])
Alzheimer's Disease Probable | Impaired cognition | Memory impairment | Aphasia | Apraxia | Agnosia | Executive dysfunction
Item
patient fulfills diagnostic and statistical manual of mental disorders (dsm-iv) and national institute of neurological and communicative disorders and stroke, alzheimer's disease and related disorders association (nincds-adrda) criteria for probable alzheimer's disease (ad), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
boolean
C0002395 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2])
C0233794 (UMLS CUI [3])
C0003537 (UMLS CUI [4])
C0003635 (UMLS CUI [5])
C0001816 (UMLS CUI [6])
C2748208 (UMLS CUI [7])
Mild dementia Mini-mental status exam score (___/30) | Moderate dementia Mini-mental status exam score (___/30) | Mild dementia Clinical dementia rating scale | Moderate dementia Clinical dementia rating scale
Item
patient has mild to moderate dementia with a dementia score of >/= 20 on the mini mental state examination (mmse) / with a clinical dementia rating score of 1 or 2 (cdr)
boolean
C3494623 (UMLS CUI [1,1])
C2225229 (UMLS CUI [1,2])
C3494871 (UMLS CUI [2,1])
C2225229 (UMLS CUI [2,2])
C3494623 (UMLS CUI [3,1])
C0451074 (UMLS CUI [3,2])
C3494871 (UMLS CUI [4,1])
C0451074 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
All
Item
all:
boolean
C0444868 (UMLS CUI [1])
Disease Significant Absent | Drug use Absent
Item
no significant disease or drug use
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0242510 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patients Imaging of brain
Item
patients for brain imaging:
boolean
C0030705 (UMLS CUI [1,1])
C0203860 (UMLS CUI [1,2])
Nervous system disorder Other | Mental disorder Other
Item
evidence for any other neurological or psychiatric disease
boolean
C0027765 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Healthy Volunteers Imaging of brain
Item
healthy volunteers for brain imaging:
boolean
C1708335 (UMLS CUI [1,1])
C0203860 (UMLS CUI [1,2])
Family history of Alzheimer's disease | First Degree Relative | Second Degree Relative | Age
Item
family history of alzheimer's disease in a 1st or 2nd degree relative under 75 years of age
boolean
C1271045 (UMLS CUI [1])
C1517194 (UMLS CUI [2])
C1519210 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
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