ID

43439

Description

ODM derived from http://clinicaltrials.gov/show/NCT00750282

Link

http://clinicaltrials.gov/show/NCT00750282

Keywords

  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00750282 Alzheimer Disease

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 55 Years
Description

age at least 55 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60. Or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
Description

Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60. Or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)

Data type

boolean

Alias
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0205359
SNOMED CT 2011_0131
5054005
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Has at least 6 years of education
Description

Has at least 6 years of education

Data type

boolean

Alias
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
CL357394
Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
Description

Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Possesses a general health that permits adequate compliance with all study procedures
Description

Possesses a general health that permits adequate compliance with all study procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0031206
SNOMED CT 2011_0131
405153007
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680734
The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
Description

The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
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
C0033204
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
Description

Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Healthy Subject
Description

Inclusion criteria for HV only:

Data type

boolean

Alias
UMLS CUI 2011AA
C1708335
Has no evidence of cognitive impairment
Description

Has no evidence of cognitive impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C0338656
SNOMED CT 2011_0131
386806002
MedDRA 14.1
10009846
Has MRI brain scan that has been judged as normal (age-appropriate)
Description

Has MRI brain scan that has been judged as normal (age-appropriate)

Data type

boolean

Alias
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0853516
MedDRA 14.1
10061944
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0814634
Alzheimer's Disease
Description

Inclusion criteria for patients with AD only:

Data type

boolean

Alias
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
Presents with positive assessment for dementia of Alzheimer's type
Description

Presents with positive assessment for dementia of Alzheimer's type

Data type

boolean

Alias
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Does not fulfill the criteria DLB or VaD
Description

Does not fulfill the criteria DLB or VaD

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0752347
SNOMED CT 2011_0131
80098002
MedDRA 14.1
10067889
ICD-10-CM Version 2010
G31.83
ICD-9-CM Version 2011
331.82
UMLS CUI 2011AA
C0011269
SNOMED CT 2011_0131
429998004
MedDRA 14.1
10057678
ICD-10-CM Version 2010
F01
ICD-9-CM Version 2011
290.4
MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
Description

MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0596217
MedDRA 14.1
10061500
UMLS CUI 2011AA
C0521090
SNOMED CT 2011_0131
71653005
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0205246
SNOMED CT 2011_0131
60132005
UMLS CUI 2011AA
C0007820
SNOMED CT 2011_0131
62914000
MedDRA 14.1
10008196
ICD-10-CM Version 2010
I67.9
ICD-9-CM Version 2011
437.9
Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Description

Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver

Data type

boolean

Alias
UMLS CUI 2011AA
C0085537
SNOMED CT 2011_0131
133932002
MedDRA 14.1
10007664
UMLS CUI 2011AA
C2827364
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0033920
SNOMED CT 2011_0131
307809000
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Has any contraindication to MRI examination scan
Description

Has any contraindication to MRI examination scan

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0917711
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
Description

Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application

Data type

boolean

Alias
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0348025
SNOMED CT 2011_0131
129236007
MedDRA 14.1
10053756
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0917914
UMLS CUI 2011AA
CL025718
Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
Description

Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0917914
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0002092
SNOMED CT 2011_0131
90260006
UMLS CUI 2011AA
C0155877
SNOMED CT 2011_0131
389145006
MedDRA 14.1
10001705
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493.0
is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
Description

is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable

Data type

boolean

Alias
UMLS CUI 2011AA
C0010340
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0681842
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
Description

Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0015333
SNOMED CT 2011_0131
218190002
MedDRA 14.1
10063155
ICD-9-CM Version 2011
E926.9
UMLS CUI 2011AA
C0521127
SNOMED CT 2011_0131
87923000
UMLS CUI 2011AA
C0034619
Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
Description

Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)

Data type

boolean

Alias
UMLS CUI 2011AA
CL428482
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0231241
SNOMED CT 2011_0131
255341006
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C0220806
SNOMED CT 2011_0131
441900009
HL7 V3 2006_05
CHEM
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0549193
SNOMED CT 2011_0131
246446004
UMLS CUI 2011AA
C0879626
SNOMED CT 2011_0131
281647001
MedDRA 14.1
10067484
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
Description

Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008972
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0182638
SNOMED CT 2011_0131
349358000
Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
Description

Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0006118
SNOMED CT 2011_0131
126952004
MedDRA 14.1
10061019
ICD-9-CM Version 2011
239.6
UMLS CUI 2011AA
C0521653
SNOMED CT 2011_0131
95638000
UMLS CUI 2011AA
C0234558
SNOMED CT 2011_0131
2432006
UMLS CUI 2011AA
C0020258
SNOMED CT 2011_0131
30753002
MedDRA 14.1
10029773
ICD-10-CM Version 2010
G91.2
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018674
SNOMED CT 2011_0131
82271004
MedDRA 14.1
10019196
ICD-10-CM Version 2010
S09.90
ICD-9-CM Version 2011
959.01
UMLS CUI 2011AA
C0195775
SNOMED CT 2011_0131
70586009
MedDRA 14.1
10061732
Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
Description

Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0333348
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
40733004
MedDRA 14.1
10021881
LOINC Version 232
MTHU034915
ICD-9-CM Version 2011
136.9
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0039128
SNOMED CT 2011_0131
76272004
MedDRA 14.1
10062120
ICD-10-CM Version 2010
A53.9
ICD-9-CM Version 2011
097.9
UMLS CUI 2011AA
C0022336
SNOMED CT 2011_0131
792004
MedDRA 14.1
10011384
ICD-10-CM Version 2010
A81.00
ICD-9-CM Version 2011
046.1
Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
Description

Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0311392
SNOMED CT 2011_0131
72670004
LOINC Version 232
MTHU001426
UMLS CUI 2011AA
C0587081
SNOMED CT 2011_0131
118246004
UMLS CUI 2011AA
C0011923
SNOMED CT 2011_0131
363679005
UMLS CUI 2011AA
C0243095
UMLS CUI 2011AA
CL335836
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
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
Description

Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0678908
UMLS CUI 2011AA
C0042847
SNOMED CT 2011_0131
190634004
MedDRA 14.1
10047609
ICD-10-CM Version 2010
E53.8
UMLS CUI 2011AA
C0016412
SNOMED CT 2011_0131
190633005
MedDRA 14.1
10016880
ICD-10-CM Version 2010
E53.8
UMLS CUI 2011AA
C0348024
SNOMED CT 2011_0131
264580006
MedDRA 14.1
10013907
Has a history of alcohol or drug abuse
Description

Has a history of alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Has history of severe persistent depression
Description

Has history of severe persistent depression

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 55 Years
Item
Age at least 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60. Or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
Item
Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60. Or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0205359 (UMLS CUI 2011AA)
5054005 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Has at least 6 years of education
Item
Has at least 6 years of education
boolean
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL357394 (UMLS CUI 2011AA)
Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
Item
Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
boolean
C0021430 (UMLS CUI 2011AA)
Possesses a general health that permits adequate compliance with all study procedures
Item
Possesses a general health that permits adequate compliance with all study procedures
boolean
C0031206 (UMLS CUI 2011AA)
405153007 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
Item
The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
boolean
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
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)
C0033204 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
Item
Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
boolean
C0021430 (UMLS CUI 2011AA)
Inclusion criteria for HV only:
Item
Healthy Subject
boolean
C1708335 (UMLS CUI 2011AA)
Has no evidence of cognitive impairment
Item
Has no evidence of cognitive impairment
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C0338656 (UMLS CUI 2011AA)
386806002 (SNOMED CT 2011_0131)
10009846 (MedDRA 14.1)
Has MRI brain scan that has been judged as normal (age-appropriate)
Item
Has MRI brain scan that has been judged as normal (age-appropriate)
boolean
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0853516 (UMLS CUI 2011AA)
10061944 (MedDRA 14.1)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0814634 (UMLS CUI 2011AA)
Inclusion criteria for patients with AD only:
Item
Alzheimer's Disease
boolean
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)
Presents with positive assessment for dementia of Alzheimer's type
Item
Presents with positive assessment for dementia of Alzheimer's type
boolean
CL415097 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Does not fulfill the criteria DLB or VaD
Item
Does not fulfill the criteria DLB or VaD
boolean
C1518422 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
C0752347 (UMLS CUI 2011AA)
80098002 (SNOMED CT 2011_0131)
10067889 (MedDRA 14.1)
G31.83 (ICD-10-CM Version 2010)
331.82 (ICD-9-CM Version 2011)
C0011269 (UMLS CUI 2011AA)
429998004 (SNOMED CT 2011_0131)
10057678 (MedDRA 14.1)
F01 (ICD-10-CM Version 2010)
290.4 (ICD-9-CM Version 2011)
MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
Item
MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
boolean
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0596217 (UMLS CUI 2011AA)
10061500 (MedDRA 14.1)
C0521090 (UMLS CUI 2011AA)
71653005 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0205246 (UMLS CUI 2011AA)
60132005 (SNOMED CT 2011_0131)
C0007820 (UMLS CUI 2011AA)
62914000 (SNOMED CT 2011_0131)
10008196 (MedDRA 14.1)
I67.9 (ICD-10-CM Version 2010)
437.9 (ICD-9-CM Version 2011)
Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Item
Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
boolean
C0085537 (UMLS CUI 2011AA)
133932002 (SNOMED CT 2011_0131)
10007664 (MedDRA 14.1)
C2827364 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0033920 (UMLS CUI 2011AA)
307809000 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Has any contraindication to MRI examination scan
Item
Has any contraindication to MRI examination scan
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0917711 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
Item
Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
boolean
C0086960 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0348025 (UMLS CUI 2011AA)
129236007 (SNOMED CT 2011_0131)
10053756 (MedDRA 14.1)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0917914 (UMLS CUI 2011AA)
CL025718 (UMLS CUI 2011AA)
Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
Item
Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0917914 (UMLS CUI 2011AA)
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C0002092 (UMLS CUI 2011AA)
90260006 (SNOMED CT 2011_0131)
C0155877 (UMLS CUI 2011AA)
389145006 (SNOMED CT 2011_0131)
10001705 (MedDRA 14.1)
J45 (ICD-10-CM Version 2010)
493.0 (ICD-9-CM Version 2011)
is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
Item
is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
boolean
C0010340 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0681842 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
Item
Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0015333 (UMLS CUI 2011AA)
218190002 (SNOMED CT 2011_0131)
10063155 (MedDRA 14.1)
E926.9 (ICD-9-CM Version 2011)
C0521127 (UMLS CUI 2011AA)
87923000 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
Item
Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
boolean
CL428482 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0231241 (UMLS CUI 2011AA)
255341006 (SNOMED CT 2011_0131)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C0220806 (UMLS CUI 2011AA)
441900009 (SNOMED CT 2011_0131)
CHEM (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0549193 (UMLS CUI 2011AA)
246446004 (SNOMED CT 2011_0131)
C0879626 (UMLS CUI 2011AA)
281647001 (SNOMED CT 2011_0131)
10067484 (MedDRA 14.1)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
Item
Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008972 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0182638 (UMLS CUI 2011AA)
349358000 (SNOMED CT 2011_0131)
Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
Item
Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
boolean
C0006118 (UMLS CUI 2011AA)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0521653 (UMLS CUI 2011AA)
95638000 (SNOMED CT 2011_0131)
C0234558 (UMLS CUI 2011AA)
2432006 (SNOMED CT 2011_0131)
C0020258 (UMLS CUI 2011AA)
30753002 (SNOMED CT 2011_0131)
10029773 (MedDRA 14.1)
G91.2 (ICD-10-CM Version 2010)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018674 (UMLS CUI 2011AA)
82271004 (SNOMED CT 2011_0131)
10019196 (MedDRA 14.1)
S09.90 (ICD-10-CM Version 2010)
959.01 (ICD-9-CM Version 2011)
C0195775 (UMLS CUI 2011AA)
70586009 (SNOMED CT 2011_0131)
10061732 (MedDRA 14.1)
Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
Item
Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
boolean
C0333348 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0039128 (UMLS CUI 2011AA)
76272004 (SNOMED CT 2011_0131)
10062120 (MedDRA 14.1)
A53.9 (ICD-10-CM Version 2010)
097.9 (ICD-9-CM Version 2011)
C0022336 (UMLS CUI 2011AA)
792004 (SNOMED CT 2011_0131)
10011384 (MedDRA 14.1)
A81.00 (ICD-10-CM Version 2010)
046.1 (ICD-9-CM Version 2011)
Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
Item
Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0311392 (UMLS CUI 2011AA)
72670004 (SNOMED CT 2011_0131)
MTHU001426 (LOINC Version 232)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0011923 (UMLS CUI 2011AA)
363679005 (SNOMED CT 2011_0131)
C0243095 (UMLS CUI 2011AA)
CL335836 (UMLS CUI 2011AA)
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)
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)
Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
Item
Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0678908 (UMLS CUI 2011AA)
C0042847 (UMLS CUI 2011AA)
190634004 (SNOMED CT 2011_0131)
10047609 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
C0016412 (UMLS CUI 2011AA)
190633005 (SNOMED CT 2011_0131)
10016880 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
C0348024 (UMLS CUI 2011AA)
264580006 (SNOMED CT 2011_0131)
10013907 (MedDRA 14.1)
Has a history of alcohol or drug abuse
Item
Has a history of alcohol or drug abuse
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Has history of severe persistent depression
Item
Has history of severe persistent depression
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205322 (UMLS CUI 2011AA)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)

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