ID

31400

Description

Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01028053

Lien

https://clinicaltrials.gov/show/NCT01028053

Mots-clés

Versions (1)
  1. 19/08/2018 19/08/2018 -
Détendeur de droits

see clinicaltrials.gov

Téléchargé le

19 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT01028053

Anglais

Eligibility Mild Cognitive Impairment NCT01028053

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject is 60 years old or older.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
the subject meets the petersen criteria for amnestic mci.
Description

Mild cognitive disorder; criteria; Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C1270972
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
the subject has a score of less than or equal to 4 on the modified hachinski ischemic scale.
Description

Modified Hachinski Ischemic Scale-NACC Version Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3826978
the subject has a mmse score of 24-30.
Description

mini-mental status exam score (___/30)

Type de données

boolean

Alias
UMLS CUI [1]
C2225229
the subject has a non-contrast mri examination as part of the screening visit that excludes amci arising from structural causes.
Description

MRI without contrast; visit for screening exam | Mild cognitive disorder; Amnestic Disorder; Structural brain disorders; Exclude

Type de données

boolean

Alias
UMLS CUI [1,1]
C0202670
UMLS CUI [1,2]
C2097637
UMLS CUI [2,1]
C1270972
UMLS CUI [2,2]
C0002625
UMLS CUI [2,3]
C0851391
UMLS CUI [2,4]
C0332196
the subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has any significant neurologic disease other than suspected amci; such as parkinson's disease, huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
Description

nervous system disorder; Significant | Mild cognitive disorder; Amnestic Disorder; Other | Parkinson Disease | Huntington Disease | Hydrocephalus, Normal Pressure | Brain Neoplasms | Supranuclear paralysis | Epilepsy | Hematoma, Subdural | Multiple Sclerosis | Craniocerebral Trauma; Neurologic Deficits; Persistent | Structural brain abnormalities

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1270972
UMLS CUI [2,2]
C0002625
UMLS CUI [2,3]
C0205394
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0020179
UMLS CUI [5]
C0020258
UMLS CUI [6]
C0006118
UMLS CUI [7]
C0270920
UMLS CUI [8]
C0014544
UMLS CUI [9]
C0018946
UMLS CUI [10]
C0026769
UMLS CUI [11,1]
C0018674
UMLS CUI [11,2]
C0521654
UMLS CUI [11,3]
C0205322
UMLS CUI [12]
C1866933
the subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an mri.
Description

Aneurysm clip | Heart Valve Prosthesis | Implants; Metals | Fragment of (qualifier value); Metals | Pacemakers | Magnetic Resonance Imaging; risk factors

Type de données

boolean

Alias
UMLS CUI [1]
C0179977
UMLS CUI [2]
C0018825
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0025552
UMLS CUI [4,1]
C0332255
UMLS CUI [4,2]
C0025552
UMLS CUI [5]
C0810633
UMLS CUI [6,1]
C0024485
UMLS CUI [6,2]
C0035648
the subject has major depression, bipolar disorder, as described in the dsm-iv within the past year.
Description

Major Depressive Disorder | Bipolar Disorder | DSM-IV; Past Year

Type de données

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0005586
UMLS CUI [3,1]
C0220952
UMLS CUI [3,2]
C4086728
the subject has history of schizophrenia (dsm-iv criteria).
Description

Schizophrenia | DSM-IV

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0220952
the subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
Description

Psychotic symptom; Time | Agitation; Time | Behavior Disorders; Time | Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0085631
UMLS CUI [2,2]
C0040223
UMLS CUI [3,1]
C0004930
UMLS CUI [3,2]
C0040223
UMLS CUI [4]
C0525058
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Similar models

Eligibility Mild Cognitive Impairment NCT01028053

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
the subject is 60 years old or older.
boolean
C0001779 (UMLS CUI [1])
Mild cognitive disorder; criteria; Fulfill
Item
the subject meets the petersen criteria for amnestic mci.
boolean
C1270972 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Modified Hachinski Ischemic Scale-NACC Version Questionnaire
Item
the subject has a score of less than or equal to 4 on the modified hachinski ischemic scale.
boolean
C3826978 (UMLS CUI [1])
mini-mental status exam score (___/30)
Item
the subject has a mmse score of 24-30.
boolean
C2225229 (UMLS CUI [1])
MRI without contrast; visit for screening exam | Mild cognitive disorder; Amnestic Disorder; Structural brain disorders; Exclude
Item
the subject has a non-contrast mri examination as part of the screening visit that excludes amci arising from structural causes.
boolean
C0202670 (UMLS CUI [1,1])
C2097637 (UMLS CUI [1,2])
C1270972 (UMLS CUI [2,1])
C0002625 (UMLS CUI [2,2])
C0851391 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
Informed Consent
Item
the subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
nervous system disorder; Significant | Mild cognitive disorder; Amnestic Disorder; Other | Parkinson Disease | Huntington Disease | Hydrocephalus, Normal Pressure | Brain Neoplasms | Supranuclear paralysis | Epilepsy | Hematoma, Subdural | Multiple Sclerosis | Craniocerebral Trauma; Neurologic Deficits; Persistent | Structural brain abnormalities
Item
the subject has any significant neurologic disease other than suspected amci; such as parkinson's disease, huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1270972 (UMLS CUI [2,1])
C0002625 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0030567 (UMLS CUI [3])
C0020179 (UMLS CUI [4])
C0020258 (UMLS CUI [5])
C0006118 (UMLS CUI [6])
C0270920 (UMLS CUI [7])
C0014544 (UMLS CUI [8])
C0018946 (UMLS CUI [9])
C0026769 (UMLS CUI [10])
C0018674 (UMLS CUI [11,1])
C0521654 (UMLS CUI [11,2])
C0205322 (UMLS CUI [11,3])
C1866933 (UMLS CUI [12])
Aneurysm clip | Heart Valve Prosthesis | Implants; Metals | Fragment of (qualifier value); Metals | Pacemakers | Magnetic Resonance Imaging; risk factors
Item
the subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an mri.
boolean
C0179977 (UMLS CUI [1])
C0018825 (UMLS CUI [2])
C0021102 (UMLS CUI [3,1])
C0025552 (UMLS CUI [3,2])
C0332255 (UMLS CUI [4,1])
C0025552 (UMLS CUI [4,2])
C0810633 (UMLS CUI [5])
C0024485 (UMLS CUI [6,1])
C0035648 (UMLS CUI [6,2])
Major Depressive Disorder | Bipolar Disorder | DSM-IV; Past Year
Item
the subject has major depression, bipolar disorder, as described in the dsm-iv within the past year.
boolean
C1269683 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0220952 (UMLS CUI [3,1])
C4086728 (UMLS CUI [3,2])
Schizophrenia | DSM-IV
Item
the subject has history of schizophrenia (dsm-iv criteria).
boolean
C0036341 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
Psychotic symptom; Time | Agitation; Time | Behavior Disorders; Time | Protocol Compliance
Item
the subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
boolean
C0871189 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0085631 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0004930 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4])
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