ID
43622
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.
Mots-clés
Versions (2)
- 20/09/2017 20/09/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
Glaxo Smith Klyne
Téléchargé le
20 septembre 2021
DOI
Pour une demande vous connecter.
Licence
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Centre or investigator number
Type de données
integer
Alias
- UMLS CUI [1]
- C2826689
Description
Visit Date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Type de données
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
Type de données
date
Alias
- UMLS CUI [1]
- C0574845
Description
Date of diagnosis of probable AD
Type de données
date
Alias
- UMLS CUI [1,1]
- C0332148
- UMLS CUI [1,2]
- C0011008
Description
Significant worsening
Type de données
boolean
Alias
- UMLS CUI [1]
- C0332271
Description
family history of AD
Type de données
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0002395
Description
First degree relative
Type de données
text
Alias
- UMLS CUI [1]
- C1517194
Description
Other relative
Type de données
text
Alias
- UMLS CUI [1]
- C3174795
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Type de données
integer
Alias
- UMLS CUI [1]
- C0489786
Description
Weight
Type de données
integer
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure
Type de données
integer
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure
Type de données
integer
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C2459822
Description
Balance assessment
Type de données
text
Alias
- UMLS CUI [1]
- C0560184
Description
Coordination
Type de données
text
Alias
- UMLS CUI [1]
- C0242414
Description
Cranial nerves
Type de données
text
Alias
- UMLS CUI [1]
- C0010268
Description
Motor system
Type de données
text
Alias
- UMLS CUI [1]
- C0026606
Description
Sensory system
Type de données
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal edema
Type de données
integer
Alias
- UMLS CUI [1]
- C0574002
Description
Tobacco use
Alias
- UMLS CUI-1
- C0038586
- UMLS CUI-2
- C0543414
Description
includes all tobacco products
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0841002
Description
Former smoker
Type de données
date
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C4288952
Description
If current or former smoker, answer the following questions
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C1519386
Description
If current or former smoker, answer the following questions
Type de données
integer
Unités de mesure
- 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
Type de données
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3176928
Description
Concomitant Medication
Description
Medication Name
Type de données
text
Alias
- UMLS CUI [1]
- C2360065
Description
Total Daily Dose
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Description
Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Description
Route of administration
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
i.e "Headache"
Type de données
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Day Month Year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Day Month Year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Ongoing Medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826666
Description
Screening summary
Alias
- UMLS CUI-1
- C1710032
- UMLS CUI-2
- C0242482
Description
Collection date fasting samples
Type de données
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.
Type de données
text
Alias
- UMLS CUI [1]
- C0032976
Description
Date of 12 lead ECG
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Description
ECG result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
ECG result
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C3539657
Description
Note: A score of 16-26 is required for a subject to be eligible for this study
Type de données
integer
Alias
- UMLS CUI [1]
- C0451306
Description
Eligibility Assessment
Type de données
text
Alias
- UMLS CUI [1]
- C0013893
Description
Alzheimer's Disease Assessment Scale
Type de données
text
Alias
- UMLS CUI [1]
- C0450989
Description
Investigator instruction
Type de données
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.
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C2243117
- UMLS CUI [1,2]
- C2700377
Description
Eligibility Assessment
Type de données
text
Alias
- UMLS CUI [1]
- C0013893
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1516637
- UMLS CUI-2
- C1512693
Description
Eligibility
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0002395
Description
mild to moderate Alzheimer's disease
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0002395
- UMLS CUI [1,2]
- C0451306
Description
Age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Concomitant medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Post-menopausal or if of childbearing potential use effective contraceptive method
Type de données
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
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0239622
- UMLS CUI [1,3]
- C0332197
Description
Compliance behavior
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321605
Description
Caregiver
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085537
Description
Caregiver informed consent
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085537
- UMLS CUI [1,2]
- C0021430
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Fasting plasma glucose measurement and Hemoglobin measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0583513
- UMLS CUI [2]
- C0518015
Description
congestive heart failure New York Heart Association criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Description
Ejection fraction measurement, ECG abnormalities
Type de données
boolean
Alias
- UMLS CUI [1]
- C2020641
- UMLS CUI [2]
- C0522055
Description
Medical history of cardiovascular event,significant arrhythmia or major intervention
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011269
Description
history or evidence of CNS disorder
Type de données
boolean
Alias
- UMLS CUI [1]
- C0455508
Description
(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Description
peripheral edema
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085649
Description
Hypertensive disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0020538
Description
Anemia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0002871
Description
Renal dysfunction
Type de données
boolean
Alias
- UMLS CUI [1]
- C3279454
Description
Liver diseases
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023895
Description
Fasting triglyceride measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0582824
Description
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013893
- UMLS CUI [1,2]
- C0036464
Description
Blood Donation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Substance use disorder
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Compliance behavior limited
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Description
Family member of research personnel
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C0086282
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator Signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date of completion
Type de données
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])
C0522055 (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])