ID
25793
Beskrivning
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.
Nyckelord
Versioner (2)
- 2017-09-20 2017-09-20 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
Glaxo Smith Klyne
Uppladdad den
20 september 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit
Screening Visit
- StudyEvent: ODM
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Subject Identifier
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Centre or investigator number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826689
Beskrivning
Visit Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Alzheimers disease diagnosis and course
Alias
- UMLS CUI-1
- C0002395
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C0449259
Beskrivning
Date of first symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Date of diagnosis of probable AD
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0332148
- UMLS CUI [1,2]
- C0011008
Beskrivning
Significant worsening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0332271
Beskrivning
family history of AD
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0002395
Beskrivning
First degree relative
Datatyp
text
Alias
- UMLS CUI [1]
- C1517194
Beskrivning
Other relative
Datatyp
text
Alias
- UMLS CUI [1]
- C3174795
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Height
Datatyp
integer
Alias
- UMLS CUI [1]
- C0489786
Beskrivning
Weight
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Education History
Alias
- UMLS CUI-1
- C0013622
Beskrivning
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Gait assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C2459822
Beskrivning
Balance assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C0560184
Beskrivning
Coordination
Datatyp
text
Alias
- UMLS CUI [1]
- C0242414
Beskrivning
Cranial nerves
Datatyp
text
Alias
- UMLS CUI [1]
- C0010268
Beskrivning
Motor system
Datatyp
text
Alias
- UMLS CUI [1]
- C0026606
Beskrivning
Sensory system
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Pedal Edema
Alias
- UMLS CUI-1
- C0013604
Beskrivning
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beskrivning
Pedal edema
Datatyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beskrivning
Tobacco use
Alias
- UMLS CUI-1
- C0038586
- UMLS CUI-2
- C0543414
Beskrivning
includes all tobacco products
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0841002
Beskrivning
Former smoker
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C4288952
Beskrivning
If current or former smoker, answer the following questions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beskrivning
If current or former smoker, answer the following questions
Datatyp
integer
Måttenheter
- yrs
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beskrivning
Medical condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0009488
Beskrivning
CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3176928
Beskrivning
Concomitant Medication
Beskrivning
Medication Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Total Daily Dose
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beskrivning
Route of administration
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
i.e "Headache"
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
Day Month Year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Day Month Year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Ongoing Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Screening summary
Alias
- UMLS CUI-1
- C1710032
- UMLS CUI-2
- C0242482
Beskrivning
Collection date fasting samples
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2348510
Beskrivning
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Date of 12 lead ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Beskrivning
ECG result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beskrivning
ECG result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beskrivning
Note: A score of 0-7 is required for a subject to be eligible for this study
Datatyp
integer
Alias
- UMLS CUI [1]
- C3539657
Beskrivning
Note: A score of 16-26 is required for a subject to be eligible for this study
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451306
Beskrivning
Eligibility Assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C0013893
Beskrivning
Alzheimer's Disease Assessment Scale
Datatyp
text
Alias
- UMLS CUI [1]
- C0450989
Beskrivning
Investigator instruction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442085
Beskrivning
Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C2243117
- UMLS CUI [1,2]
- C2700377
Beskrivning
Eligibility Assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C0013893
Beskrivning
Inclusion criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C1512693
Beskrivning
Eligibility
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beskrivning
(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0002395
Beskrivning
mild to moderate Alzheimer's disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0451306
Beskrivning
Age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Concomitant medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Post-menopausal or if of childbearing potential use effective contraceptive method
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232970
- UMLS CUI [2,1]
- C3831118
- UMLS CUI [2,2]
- C0700589
Beskrivning
CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0006118
- UMLS CUI [1,2]
- C0332197
- UMLS CUI [2,1]
- C4021085
- UMLS CUI [2,2]
- C0332197
- UMLS CUI [3,1]
- C0524851
- UMLS CUI [3,2]
- C0205394
- UMLS CUI [3,3]
- C0332197
Beskrivning
Neurological exam without focal changes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0239622
- UMLS CUI [1,3]
- C0332197
Beskrivning
Compliance behavior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Caregiver
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085537
Beskrivning
Caregiver informed consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Beskrivning
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Diabetes mellitus
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beskrivning
Fasting plasma glucose measurement and Hemoglobin measurement
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0583513
- UMLS CUI [2]
- C0518015
Beskrivning
congestive heart failure New York Heart Association criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Beskrivning
Ejection fraction measurement, ECG abnormalities
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2020641
- UMLS CUI [2]
- C1832603
Beskrivning
Medical history of cardiovascular event,significant arrhythmia or major intervention
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1320716
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0003811
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0018821
Beskrivning
vascular dementia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011269
Beskrivning
history or evidence of CNS disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0455508
Beskrivning
(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beskrivning
peripheral edema
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085649
Beskrivning
Hypertensive disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020538
Beskrivning
Anemia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002871
Beskrivning
Renal dysfunction
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3279454
Beskrivning
Liver diseases
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023895
Beskrivning
Fasting triglyceride measurement
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0582824
Beskrivning
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0202252
- UMLS CUI [2,1]
- C0022885
- UMLS CUI [2,2]
- C0919842
- UMLS CUI [3,1]
- C0022885
- UMLS CUI [3,2]
- C0202230
Beskrivning
Eligibility Determination, other relevant conditions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C0036464
Beskrivning
Blood Donation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005794
Beskrivning
Substance use disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beskrivning
Compliance behavior limited
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beskrivning
Family member of research personnel
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C0086282
Beskrivning
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date of completion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Similar models
Screening Visit
- StudyEvent: ODM
C0011900 (UMLS CUI-2)
C0449259 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0841002 (UMLS CUI [1,2])
C4288952 (UMLS CUI [1,2])
C1519386 (UMLS CUI [1,2])
C1519386 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C3176928 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2348510 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
C2700377 (UMLS CUI [1,2])
C1512693 (UMLS CUI-2)
C0002395 (UMLS CUI [1,2])
C0451306 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [1,2])
C4021085 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0524851 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0239622 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C1275491 (UMLS CUI [1,2])
C1832603 (UMLS CUI [2])
C1320716 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0018821 (UMLS CUI [3,2])
C0004936 (UMLS CUI [1,2])
C0202252 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0919842 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3,1])
C0202230 (UMLS CUI [3,2])
C0036464 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])