ID
25883
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 (3)
- 2017-09-21 2017-09-21 -
- 2017-09-21 2017-09-21 -
- 2017-09-25 2017-09-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 september 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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Visit 6-8 plus Follow-up
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Beskrivning
Visit 7
Alias
- UMLS CUI-1
- C0545082
Beskrivning
Subject Identifier
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Visit Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Subject Continuation
Datatyp
text
Alias
- UMLS CUI [1]
- C0805733
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Central Laboratory (fasting samples)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0015663
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1317250
Beskrivning
Concomitant Medications
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Adverse Events
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
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. Note: Use the same ankle throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beskrivning
Pedal edema
Datatyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beskrivning
ADAS-cog CIBIC+ NPI DAD
Datatyp
text
Alias
- UMLS CUI [1]
- C0681889
Beskrivning
Alzheimer Disease Assessment Scale
Datatyp
text
Alias
- UMLS CUI [1]
- C0450989
Beskrivning
Clinician Interview-Based Impression of Change
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641327
Beskrivning
NPI
Datatyp
text
Alias
- UMLS CUI [1]
- C3539727
Beskrivning
Disability Assessment for Dementia Questionnaire
Datatyp
text
Alias
- UMLS CUI [1]
- C3641946
Beskrivning
Monitor Data Validation Checks
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519941
- UMLS CUI [1,2]
- C0030695
Beskrivning
Investigator Instructions
Datatyp
text
Alias
- UMLS CUI [1]
- C1442085
Beskrivning
Previous bottle: turn to the lnvestigational Product/Compliance section for the previous visit to record the stop date and number of tablets returned, and to answer the question 'Has the subject missed taking investigation al product for >7 consecutive days?' New bottle: dispense two bottles of study medication as specified by the IVRS system. Record start date (for bottle 5), container numbers and number of tablets dispensed below (start date for bottle 6, stop dates and tablets returned will be completed when the bottle is returned).
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Investigational Product
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Investigational Product
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
IP Container Number
Datatyp
text
Alias
- UMLS CUI [1]
- C0180098
Beskrivning
IP Container Number
Datatyp
text
Alias
- UMLS CUI [1]
- C0180098
Beskrivning
Compliance
Datatyp
text
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Total number of Tablets Dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beskrivning
Total number of Tablets Dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beskrivning
Total number of Tablets Returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beskrivning
Total number of Tablets Returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beskrivning
Discontinuation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beskrivning
End of Visit Reminder
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beskrivning
Visit 8
Alias
- UMLS CUI-1
- C0545082
Beskrivning
Investigator Instructions
Datatyp
text
Alias
- UMLS CUI [1]
- C1442085
Beskrivning
Subject Identifier
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Visit Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Neurological Examination
Datatyp
text
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
Central Laboratory ( fasting samples)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0015663
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1317250
Beskrivning
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Check whether informed consent for pharmacogenetic and pharmacogenomic research was obtained for this subject. Only for those subjects for whom consent was obtained, take blood samples for pharmacogenomic assessments and record the details in the following two sections.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347501
Beskrivning
Blood sample collection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
Time and date of blood sampling
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beskrivning
Blood sample collection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
Time and date of blood sampling
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beskrivning
(only one aliquot volume required since all are equal)
Datatyp
float
Måttenheter
- mL
Alias
- UMLS CUI [1]
- C2700258
Beskrivning
Centrifugation time
Datatyp
integer
Måttenheter
- minutes
Alias
- UMLS CUI [1,1]
- C0179834
- UMLS CUI [1,2]
- C0040223
Beskrivning
Centrifuge temperature
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0179834
Beskrivning
Centrifugation speed
Datatyp
integer
Måttenheter
- r.p.m
Alias
- UMLS CUI [1,1]
- C0678536
- UMLS CUI [1,2]
- C0179834
Beskrivning
Centrifuge rotor radius
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2720577
- UMLS CUI [1,2]
- C1306504
Beskrivning
Time in freezer
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0175738
- UMLS CUI [1,2]
- C0040223
Beskrivning
Temperature of freezer
Datatyp
integer
Måttenheter
- -°C
Alias
- UMLS CUI [1]
- C2957069
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
Concomitant Medications
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Adverse Events
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
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. Note: Use the same ankle throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beskrivning
Pedal edema
Datatyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beskrivning
ADAS-cog CIBIC+ NPI DAD
Datatyp
text
Alias
- UMLS CUI [1]
- C0681889
Beskrivning
Alzheimer Disease Assessment Scale
Datatyp
text
Alias
- UMLS CUI [1]
- C0450989
Beskrivning
Clinician Interview-Based Impression of Change
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3641327
Beskrivning
NPI
Datatyp
text
Alias
- UMLS CUI [1]
- C3539727
Beskrivning
Disability Assessment for Dementia Questionnaire
Datatyp
text
Alias
- UMLS CUI [1]
- C3641946
Beskrivning
Investigational Product Compliance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1321605
Beskrivning
End of Visit Reminder
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beskrivning
Study End Follow-up
Alias
- UMLS CUI-1
- C2827036
- UMLS CUI-2
- C3274571
Beskrivning
Investigator Instructions
Datatyp
text
Alias
- UMLS CUI [1]
- C1442085
Beskrivning
Subject Identifier
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Visit Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Central Laboratory (Non fasting samples)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2585491
Beskrivning
Collection Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1317250
Beskrivning
Concomitant Medications
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Adverse Events
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
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. Note: Use the same ankle throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beskrivning
Pedal edema
Datatyp
integer
Alias
- UMLS CUI [1]
- C0574002
Similar models
Visit 6-8 plus Follow-up
- StudyEvent: ODM
C2585491 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
C2347501 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
C1306504 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])