ID

4552

Description

ODM derived from http://clinicaltrials.gov/show/NCT00479557

Link

http://clinicaltrials.gov/show/NCT00479557

Keywords

Versions (1)
  1. 12/10/13 12/10/13 - Martin Dugas
Uploaded on

December 10, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00479557 Alzheimer Disease

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 50 Years to 85 Years
Description

age 50 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
Description

Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C0002395
SNOMED CT 2011_0131
26929004
MedDRA 14.1
10012271
LOINC Version 232
MTHU020798
ICD-10-CM Version 2010
G30.9
ICD-9-CM Version 2011
331.0
UMLS CUI 2011AA
C0451306
SNOMED CT 2011_0131
273617000
MedDRA 14.1
10067001
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Brain MRI consistent with Alzheimer Disease
Description

Brain MRI consistent with Alzheimer Disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0881827
LOINC Version 232
24590-2
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0002395
SNOMED CT 2011_0131
26929004
MedDRA 14.1
10012271
LOINC Version 232
MTHU020798
ICD-10-CM Version 2010
G30.9
ICD-9-CM Version 2011
331.0
Concurrent use of Cholinesterase inhibitor or memantine allowed if stable
Description

Concurrent use of Cholinesterase inhibitor or memantine allowed if stable

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0008425
SNOMED CT 2011_0131
52761007
UMLS CUI 2011AA
C0025242
SNOMED CT 2011_0131
406458000
LOINC Version 232
MTHU035864
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
Other inclusion criteria apply
Description

Other inclusion criteria apply

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
CL025718
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Significant Neurological Disease other than Alzheimer's disease
Description

Significant Neurological Disease other than Alzheimer's disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0002395
SNOMED CT 2011_0131
26929004
MedDRA 14.1
10012271
LOINC Version 232
MTHU020798
ICD-10-CM Version 2010
G30.9
ICD-9-CM Version 2011
331.0
Major psychiatric disorder
Description

Major psychiatric disorder

Data type

boolean

Alias
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Contraindication to undergo brain MRI
Description

Contraindication to undergo brain MRI

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0881827
LOINC Version 232
24590-2
Clinically significant systemic illness
Description

Clinically significant systemic illness

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
Other exclusion criteria apply
Description

Other exclusion criteria apply

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
CL025718
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 50 Years to 85 Years
Item
age 50 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
Item
Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C0002395 (UMLS CUI 2011AA)
26929004 (SNOMED CT 2011_0131)
10012271 (MedDRA 14.1)
MTHU020798 (LOINC Version 232)
G30.9 (ICD-10-CM Version 2010)
331.0 (ICD-9-CM Version 2011)
C0451306 (UMLS CUI 2011AA)
273617000 (SNOMED CT 2011_0131)
10067001 (MedDRA 14.1)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Brain MRI consistent with Alzheimer Disease
Item
Brain MRI consistent with Alzheimer Disease
boolean
C0881827 (UMLS CUI 2011AA)
24590-2 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0002395 (UMLS CUI 2011AA)
26929004 (SNOMED CT 2011_0131)
10012271 (MedDRA 14.1)
MTHU020798 (LOINC Version 232)
G30.9 (ICD-10-CM Version 2010)
331.0 (ICD-9-CM Version 2011)
Concurrent use of Cholinesterase inhibitor or memantine allowed if stable
Item
Concurrent use of Cholinesterase inhibitor or memantine allowed if stable
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0008425 (UMLS CUI 2011AA)
52761007 (SNOMED CT 2011_0131)
C0025242 (UMLS CUI 2011AA)
406458000 (SNOMED CT 2011_0131)
MTHU035864 (LOINC Version 232)
C1524004 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
Other inclusion criteria apply
Item
Other inclusion criteria apply
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
CL025718 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Significant Neurological Disease other than Alzheimer's disease
Item
Significant Neurological Disease other than Alzheimer's disease
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C1554961 (UMLS CUI 2011AA)
C0002395 (UMLS CUI 2011AA)
26929004 (SNOMED CT 2011_0131)
10012271 (MedDRA 14.1)
MTHU020798 (LOINC Version 232)
G30.9 (ICD-10-CM Version 2010)
331.0 (ICD-9-CM Version 2011)
Major psychiatric disorder
Item
Major psychiatric disorder
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
Contraindication to undergo brain MRI
Item
Contraindication to undergo brain MRI
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0881827 (UMLS CUI 2011AA)
24590-2 (LOINC Version 232)
Clinically significant systemic illness
Item
Clinically significant systemic illness
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
Other exclusion criteria apply
Item
Other exclusion criteria apply
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL425201 (UMLS CUI 2011AA)
CL025718 (UMLS CUI 2011AA)
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