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 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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