ID
25883
Beschrijving
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.
Trefwoorden
Versies (3)
- 21-09-17 21-09-17 -
- 21-09-17 21-09-17 -
- 25-09-17 25-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 september 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Visit 6-8 plus Follow-up
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Beschrijving
Visit 7
Alias
- UMLS CUI-1
- C0545082
Beschrijving
Subject Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Subject Continuation
Datatype
text
Alias
- UMLS CUI [1]
- C0805733
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Central Laboratory (fasting samples)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0015663
Beschrijving
Collection Date
Datatype
date
Alias
- UMLS CUI [1]
- C1317250
Beschrijving
Concomitant Medications
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschrijving
Pedal edema
Datatype
integer
Alias
- UMLS CUI [1]
- C0574002
Beschrijving
ADAS-cog CIBIC+ NPI DAD
Datatype
text
Alias
- UMLS CUI [1]
- C0681889
Beschrijving
Alzheimer Disease Assessment Scale
Datatype
text
Alias
- UMLS CUI [1]
- C0450989
Beschrijving
Clinician Interview-Based Impression of Change
Datatype
boolean
Alias
- UMLS CUI [1]
- C3641327
Beschrijving
NPI
Datatype
text
Alias
- UMLS CUI [1]
- C3539727
Beschrijving
Disability Assessment for Dementia Questionnaire
Datatype
text
Alias
- UMLS CUI [1]
- C3641946
Beschrijving
Monitor Data Validation Checks
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519941
- UMLS CUI [1,2]
- C0030695
Beschrijving
Investigator Instructions
Datatype
text
Alias
- UMLS CUI [1]
- C1442085
Beschrijving
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).
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Investigational Product
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Investigational Product
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschrijving
Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschrijving
IP Container Number
Datatype
text
Alias
- UMLS CUI [1]
- C0180098
Beschrijving
IP Container Number
Datatype
text
Alias
- UMLS CUI [1]
- C0180098
Beschrijving
Compliance
Datatype
text
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Total number of Tablets Dispensed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschrijving
Total number of Tablets Dispensed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschrijving
Total number of Tablets Returned
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschrijving
Total number of Tablets Returned
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschrijving
Discontinuation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschrijving
End of Visit Reminder
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beschrijving
Visit 8
Alias
- UMLS CUI-1
- C0545082
Beschrijving
Investigator Instructions
Datatype
text
Alias
- UMLS CUI [1]
- C1442085
Beschrijving
Subject Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Neurological Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Gait assessment
Datatype
text
Alias
- UMLS CUI [1]
- C2459822
Beschrijving
Balance assessment
Datatype
text
Alias
- UMLS CUI [1]
- C0560184
Beschrijving
Coordination
Datatype
text
Alias
- UMLS CUI [1]
- C0242414
Beschrijving
Cranial nerves
Datatype
text
Alias
- UMLS CUI [1]
- C0010268
Beschrijving
Motor system
Datatype
text
Alias
- UMLS CUI [1]
- C0026606
Beschrijving
Sensory system
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Beschrijving
Central Laboratory ( fasting samples)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0015663
Beschrijving
Collection Date
Datatype
date
Alias
- UMLS CUI [1]
- C1317250
Beschrijving
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347501
Beschrijving
Blood sample collection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Time and date of blood sampling
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beschrijving
Blood sample collection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Time and date of blood sampling
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beschrijving
(only one aliquot volume required since all are equal)
Datatype
float
Maateenheden
- mL
Alias
- UMLS CUI [1]
- C2700258
Beschrijving
Centrifugation time
Datatype
integer
Maateenheden
- minutes
Alias
- UMLS CUI [1,1]
- C0179834
- UMLS CUI [1,2]
- C0040223
Beschrijving
Centrifuge temperature
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0179834
Beschrijving
Centrifugation speed
Datatype
integer
Maateenheden
- r.p.m
Alias
- UMLS CUI [1,1]
- C0678536
- UMLS CUI [1,2]
- C0179834
Beschrijving
Centrifuge rotor radius
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2720577
- UMLS CUI [1,2]
- C1306504
Beschrijving
Time in freezer
Datatype
time
Alias
- UMLS CUI [1,1]
- C0175738
- UMLS CUI [1,2]
- C0040223
Beschrijving
Temperature of freezer
Datatype
integer
Maateenheden
- -°C
Alias
- UMLS CUI [1]
- C2957069
Beschrijving
Date of 12 lead ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Beschrijving
ECG result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschrijving
ECG result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschrijving
Concomitant Medications
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschrijving
Pedal edema
Datatype
integer
Alias
- UMLS CUI [1]
- C0574002
Beschrijving
ADAS-cog CIBIC+ NPI DAD
Datatype
text
Alias
- UMLS CUI [1]
- C0681889
Beschrijving
Alzheimer Disease Assessment Scale
Datatype
text
Alias
- UMLS CUI [1]
- C0450989
Beschrijving
Clinician Interview-Based Impression of Change
Datatype
boolean
Alias
- UMLS CUI [1]
- C3641327
Beschrijving
NPI
Datatype
text
Alias
- UMLS CUI [1]
- C3539727
Beschrijving
Disability Assessment for Dementia Questionnaire
Datatype
text
Alias
- UMLS CUI [1]
- C3641946
Beschrijving
Investigational Product Compliance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1321605
Beschrijving
End of Visit Reminder
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beschrijving
Study End Follow-up
Alias
- UMLS CUI-1
- C2827036
- UMLS CUI-2
- C3274571
Beschrijving
Investigator Instructions
Datatype
text
Alias
- UMLS CUI [1]
- C1442085
Beschrijving
Subject Identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Central Laboratory (Non fasting samples)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2585491
Beschrijving
Collection Date
Datatype
date
Alias
- UMLS CUI [1]
- C1317250
Beschrijving
Concomitant Medications
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschrijving
Pedal edema
Datatype
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])