ID
25793
Description
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.
Keywords
Versions (2)
- 9/20/17 9/20/17 -
- 9/20/21 9/20/21 -
Copyright Holder
Glaxo Smith Klyne
Uploaded on
September 20, 2017
DOI
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License
Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit
Screening Visit
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Subject Identifier
Data type
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Centre or investigator number
Data type
integer
Alias
- UMLS CUI [1]
- C2826689
Description
Visit Date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Alzheimers disease diagnosis and course
Alias
- UMLS CUI-1
- C0002395
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C0449259
Description
Date of first symptoms
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Date of diagnosis of probable AD
Data type
date
Alias
- UMLS CUI [1,1]
- C0332148
- UMLS CUI [1,2]
- C0011008
Description
Significant worsening
Data type
boolean
Alias
- UMLS CUI [1]
- C0332271
Description
family history of AD
Data type
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0002395
Description
First degree relative
Data type
text
Alias
- UMLS CUI [1]
- C1517194
Description
Other relative
Data type
text
Alias
- UMLS CUI [1]
- C3174795
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Data type
integer
Alias
- UMLS CUI [1]
- C0489786
Description
Weight
Data type
integer
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure
Data type
integer
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure
Data type
integer
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Alias
- UMLS CUI [1]
- C0018810
Description
Education History
Alias
- UMLS CUI-1
- C0013622
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Gait assessment
Data type
text
Alias
- UMLS CUI [1]
- C2459822
Description
Balance assessment
Data type
text
Alias
- UMLS CUI [1]
- C0560184
Description
Coordination
Data type
text
Alias
- UMLS CUI [1]
- C0242414
Description
Cranial nerves
Data type
text
Alias
- UMLS CUI [1]
- C0010268
Description
Motor system
Data type
text
Alias
- UMLS CUI [1]
- C0026606
Description
Sensory system
Data type
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Pedal Edema
Alias
- UMLS CUI-1
- C0013604
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal edema
Data type
integer
Alias
- UMLS CUI [1]
- C0574002
Description
Tobacco use
Alias
- UMLS CUI-1
- C0038586
- UMLS CUI-2
- C0543414
Description
includes all tobacco products
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0841002
Description
Former smoker
Data type
date
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C4288952
Description
If current or former smoker, answer the following questions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Description
If current or former smoker, answer the following questions
Data type
integer
Measurement units
- yrs
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Description
Medical condition
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0009488
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3176928
Description
Concomitant Medication
Description
Medication Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Total Daily Dose
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Description
Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Description
Route of administration
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
i.e "Headache"
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Day Month Year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Ongoing Medication
Data type
text
Alias
- UMLS CUI [1]
- C2826666
Description
Screening summary
Alias
- UMLS CUI-1
- C1710032
- UMLS CUI-2
- C0242482
Description
Collection date fasting samples
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2348510
Description
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Data type
text
Alias
- UMLS CUI [1]
- C0032976
Description
Date of 12 lead ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Description
ECG result
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
ECG result
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
Note: A score of 0-7 is required for a subject to be eligible for this study
Data type
integer
Alias
- UMLS CUI [1]
- C3539657
Description
Note: A score of 16-26 is required for a subject to be eligible for this study
Data type
integer
Alias
- UMLS CUI [1]
- C0451306
Description
Eligibility Assessment
Data type
text
Alias
- UMLS CUI [1]
- C0013893
Description
Alzheimer's Disease Assessment Scale
Data type
text
Alias
- UMLS CUI [1]
- C0450989
Description
Investigator instruction
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442085
Description
Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C2243117
- UMLS CUI [1,2]
- C2700377
Description
Eligibility Assessment
Data type
text
Alias
- UMLS CUI [1]
- C0013893
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C1512693
Description
Eligibility
Data type
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0002395
Description
mild to moderate Alzheimer's disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0451306
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Post-menopausal or if of childbearing potential use effective contraceptive method
Data type
boolean
Alias
- UMLS CUI [1]
- C0232970
- UMLS CUI [2,1]
- C3831118
- UMLS CUI [2,2]
- C0700589
Description
CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease
Data type
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
Description
Neurological exam without focal changes
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0239622
- UMLS CUI [1,3]
- C0332197
Description
Compliance behavior
Data type
boolean
Alias
- UMLS CUI [1]
- C1321605
Description
Caregiver
Data type
boolean
Alias
- UMLS CUI [1]
- C0085537
Description
Caregiver informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
Diabetes mellitus
Data type
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Fasting plasma glucose measurement and Hemoglobin measurement
Data type
boolean
Alias
- UMLS CUI [1]
- C0583513
- UMLS CUI [2]
- C0518015
Description
congestive heart failure New York Heart Association criteria
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Description
Ejection fraction measurement, ECG abnormalities
Data type
boolean
Alias
- UMLS CUI [1]
- C2020641
- UMLS CUI [2]
- C1832603
Description
Medical history of cardiovascular event,significant arrhythmia or major intervention
Data type
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
Description
vascular dementia
Data type
boolean
Alias
- UMLS CUI [1]
- C0011269
Description
history or evidence of CNS disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0455508
Description
(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Description
peripheral edema
Data type
boolean
Alias
- UMLS CUI [1]
- C0085649
Description
Hypertensive disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0020538
Description
Anemia
Data type
boolean
Alias
- UMLS CUI [1]
- C0002871
Description
Renal dysfunction
Data type
boolean
Alias
- UMLS CUI [1]
- C3279454
Description
Liver diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0023895
Description
Fasting triglyceride measurement
Data type
boolean
Alias
- UMLS CUI [1]
- C0582824
Description
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Data type
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
Description
Eligibility Determination, other relevant conditions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C0036464
Description
Blood Donation
Data type
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Substance use disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Compliance behavior limited
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Description
Family member of research personnel
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C0086282
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date of completion
Data type
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])
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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])