ID
25793
Beschreibung
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.
Stichworte
Versionen (2)
- 20.09.17 20.09.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
Glaxo Smith Klyne
Hochgeladen am
20. September 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit
Screening Visit
- StudyEvent: ODM
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Subject Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Centre or investigator number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826689
Beschreibung
Visit Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Alzheimers disease diagnosis and course
Alias
- UMLS CUI-1
- C0002395
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C0449259
Beschreibung
Date of first symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Date of diagnosis of probable AD
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0332148
- UMLS CUI [1,2]
- C0011008
Beschreibung
Significant worsening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0332271
Beschreibung
family history of AD
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0002395
Beschreibung
First degree relative
Datentyp
text
Alias
- UMLS CUI [1]
- C1517194
Beschreibung
Other relative
Datentyp
text
Alias
- UMLS CUI [1]
- C3174795
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Height
Datentyp
integer
Alias
- UMLS CUI [1]
- C0489786
Beschreibung
Weight
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood pressure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Education History
Alias
- UMLS CUI-1
- C0013622
Beschreibung
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Gait assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C2459822
Beschreibung
Balance assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C0560184
Beschreibung
Coordination
Datentyp
text
Alias
- UMLS CUI [1]
- C0242414
Beschreibung
Cranial nerves
Datentyp
text
Alias
- UMLS CUI [1]
- C0010268
Beschreibung
Motor system
Datentyp
text
Alias
- UMLS CUI [1]
- C0026606
Beschreibung
Sensory system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Pedal Edema
Alias
- UMLS CUI-1
- C0013604
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal edema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beschreibung
Tobacco use
Alias
- UMLS CUI-1
- C0038586
- UMLS CUI-2
- C0543414
Beschreibung
includes all tobacco products
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0841002
Beschreibung
Former smoker
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C4288952
Beschreibung
If current or former smoker, answer the following questions
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beschreibung
If current or former smoker, answer the following questions
Datentyp
integer
Maßeinheiten
- yrs
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Beschreibung
Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschreibung
Medical condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0009488
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3176928
Beschreibung
Concomitant Medication
Beschreibung
Medication Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Total Daily Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beschreibung
Route of administration
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
i.e "Headache"
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschreibung
Day Month Year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Day Month Year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Screening summary
Alias
- UMLS CUI-1
- C1710032
- UMLS CUI-2
- C0242482
Beschreibung
Collection date fasting samples
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C2348510
Beschreibung
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Date of 12 lead ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Beschreibung
ECG result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
ECG result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
Note: A score of 0-7 is required for a subject to be eligible for this study
Datentyp
integer
Alias
- UMLS CUI [1]
- C3539657
Beschreibung
Note: A score of 16-26 is required for a subject to be eligible for this study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0451306
Beschreibung
Eligibility Assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
Alzheimer's Disease Assessment Scale
Datentyp
text
Alias
- UMLS CUI [1]
- C0450989
Beschreibung
Investigator instruction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1442085
Beschreibung
Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C2243117
- UMLS CUI [1,2]
- C2700377
Beschreibung
Eligibility Assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
Inclusion criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C1512693
Beschreibung
Eligibility
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0002395
Beschreibung
mild to moderate Alzheimer's disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0451306
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Concomitant medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Post-menopausal or if of childbearing potential use effective contraceptive method
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232970
- UMLS CUI [2,1]
- C3831118
- UMLS CUI [2,2]
- C0700589
Beschreibung
CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease
Datentyp
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
Beschreibung
Neurological exam without focal changes
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0239622
- UMLS CUI [1,3]
- C0332197
Beschreibung
Compliance behavior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Caregiver
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085537
Beschreibung
Caregiver informed consent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
Fasting plasma glucose measurement and Hemoglobin measurement
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0583513
- UMLS CUI [2]
- C0518015
Beschreibung
congestive heart failure New York Heart Association criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Beschreibung
Ejection fraction measurement, ECG abnormalities
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2020641
- UMLS CUI [2]
- C1832603
Beschreibung
Medical history of cardiovascular event,significant arrhythmia or major intervention
Datentyp
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
Beschreibung
vascular dementia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011269
Beschreibung
history or evidence of CNS disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0455508
Beschreibung
(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beschreibung
peripheral edema
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085649
Beschreibung
Hypertensive disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020538
Beschreibung
Anemia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002871
Beschreibung
Renal dysfunction
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3279454
Beschreibung
Liver diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023895
Beschreibung
Fasting triglyceride measurement
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0582824
Beschreibung
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Datentyp
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
Beschreibung
Eligibility Determination, other relevant conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C0036464
Beschreibung
Blood Donation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschreibung
Substance use disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
Compliance behavior limited
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beschreibung
Family member of research personnel
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C0086282
Beschreibung
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Ähnliche Modelle
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])