Information:
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ID
25883
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 (3)
- 9/21/17 9/21/17 -
- 9/21/17 9/21/17 -
- 9/25/17 9/25/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 25, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Visit 6-8 plus Follow-up
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Similar models
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments for this visit, ans also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Esnure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
text
C0805733 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
CL Item
<1 mm (0)
CL Item
1 - 2 mm (1)
CL Item
3- 5 mm (2)
CL Item
6 - 10 mm (3)
CL Item
> 10 mm (4)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Monitor Data Validation Checks
Item
Check carefully for any overlapping start/stop dates Ensure any deviations from investigational product are recorded correctly as outlined in the study protocol.
text
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
Investigator Instructions
Item
Telephone the IVRS system to register the visit and to obtain the container number for the next bottle of study medication.
text
C1442085 (UMLS CUI [1])
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
IP Container Number
Item
IP Container No.
text
C0180098 (UMLS CUI [1])
Compliance
Item
Compliance
text
C1321605 (UMLS CUI [1])
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
End of Visit Reminder
Item
Schedule Visit 7, 16 weeks (112 days ± 7 days) after Visit 2, in the morning, and remind the subject to attend in the fasted state (no food or drink [except water] for at least 8 hours prior to the visit).
text
C1709896 (UMLS CUI [1,1])
C2827036 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
Rating scale Instructions
Item
The following scales should be completed at this visit only if the subject is withdrwan at this visit. Do not complete these assessments if the subject is continuing in the study.
boolean
C0681889 (UMLS CUI [1])
Alzheimer Disease Assessment Scale
Item
Alzheimer Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Clinician Interview-Based Impression of Change
Item
CIBIC+
boolean
C3641327 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completed appropriately. Schedule an early withdrawal follow-up visit 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
text
C0805733 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (fasting samples)
Item
Central Laboratory ( fasting samples)
text
C0022885 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
CL Item
<1 mm (0)
CL Item
1 - 2 mm (1)
CL Item
3- 5 mm (2)
CL Item
6 - 10 mm (3)
CL Item
> 10 mm (4)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Rating scale Instructions
Item
The following scales should be completed at this visit
text
C0681889 (UMLS CUI [1])
Alzheimer Disease Assessment Scale
Item
Alzheimer Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Clinician Interview-Based Impression of Change
Item
CIBIC+
boolean
C3641327 (UMLS CUI [1])
NPI
Item
Neuropsychiatric Inventory
text
C3539727 (UMLS CUI [1])
Disability Assessment for Dementia Questionnaire
Item
DAD
text
C3641946 (UMLS CUI [1])
Monitor Data Validation Checks
Item
Check carefully for any overlapping start/stop dates Ensure any deviations from investigational product are recorded correctly as outlined in the study protocol.
text
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
Investigator Instructions
Item
Telephone the IVRS system to register the visit and to obtain the container number for the next two bottles of study medication.
text
C1442085 (UMLS CUI [1])
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
C0304229 (UMLS CUI [1])
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
IP Container Number
Item
IP Container No.
text
C0180098 (UMLS CUI [1])
IP Container Number
Item
IP Container No.
text
C0180098 (UMLS CUI [1])
Compliance
Item
Compliance
text
C1321605 (UMLS CUI [1])
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
End of Visit Reminder
Item
Schedule Visit 8, 24 weeks (168 days± 7 days) after Visit 2, in the morning, and remind the subject to attend in the fasted state (no food or drink [except water] for at least 8 hours prior to the visit).
text
C1709896 (UMLS CUI [1,1])
C2827036 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
Investigator Instructions
Item
Please make a Completion call to the IVRS system.
text
C1442085 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Neurological Examination
Item
Perform a Neurological examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. Note: If any abnormalities are found as a result of the physial examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0027853 (UMLS CUI [1])
Gait assessment
Item
Gait assessment
text
C2459822 (UMLS CUI [1])
Balance assessment
Item
Balance assessment
text
C0560184 (UMLS CUI [1])
Coordination
Item
Coordination
text
C0242414 (UMLS CUI [1])
Cranial nerves
Item
Cranial nerves
text
C0010268 (UMLS CUI [1])
Motor system
Item
Motor system
text
C0026606 (UMLS CUI [1])
Sensory system
Item
Sensory system
text
C0682648 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
Central Laboratory ( fasting samples)
Item
Central Laboratory ( fasting samples)
text
C1302413 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Pregnancy test
Item
Pregnancy test
text
C0032976 (UMLS CUI [1])
Informed consent for pharmacogenetic and pharmacogenomic research
Item
Informed consent for pharmacogenetic and pharmacogenomic research
text
C0021430 (UMLS CUI [1,1])
C2347501 (UMLS CUI [1,2])
C2347501 (UMLS CUI [1,2])
Blood sample collection
Item
Has a blood sample been collected for PGm-Transcriptomic research?
boolean
C0005834 (UMLS CUI [1])
Time and date of blood sampling
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Blood sample collection
Item
Has a blood sample been collected for PGm-Proteomic research?
boolean
C0005834 (UMLS CUI [1])
Time and date of blood sampling
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Aliquot volume
Item
Volume of one aliquot
float
C2700258 (UMLS CUI [1])
Centrifugation time
Item
Length of time the centrifuge ran
integer
C0179834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
Temperature of the centrifuge
integer
C0039476 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
CL Item
Room temperature (1)
CL Item
Refrigerated centrifuge (2)
Centrifugation speed
Item
Centrifugation speed
integer
C0678536 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
Centrifuge rotor radius
Item
Centrifuge rotor radius
integer
C2720577 (UMLS CUI [1,1])
C1306504 (UMLS CUI [1,2])
C1306504 (UMLS CUI [1,2])
Time in freezer
Item
Time aliquotted samples were placed in the freezer
time
C0175738 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Temperature of freezer
Item
Temperature of freezer
integer
C2957069 (UMLS CUI [1])
Date of 12 lead ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
ECG result
Item
If ECG clinically significant abnormal ,Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
CL Item
<1 mm (0)
CL Item
1 - 2 mm (1)
CL Item
3- 5 mm (2)
CL Item
6 - 10 mm (3)
CL Item
> 10 mm (4)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Rating scale Instructions
Item
The following scales should be completed at this visit
text
C0681889 (UMLS CUI [1])
Alzheimer Disease Assessment Scale
Item
Alzheimer Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Clinician Interview-Based Impression of Change
Item
CIBIC+
boolean
C3641327 (UMLS CUI [1])
NPI
Item
Neuropsychiatric Inventory
text
C3539727 (UMLS CUI [1])
Disability Assessment for Dementia Questionnaire
Item
DAD
text
C3641946 (UMLS CUI [1])
Investigational Product Compliance
Item
Turn to the Investigational Product/ Compliance section for the previous visit to record the stop dates and number of tablets returned (Bottles 5 and 6) and to answer the question ´Has the subject missed taking investigational prodruct for > 7 consecutive days?´
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
End of Visit Reminder
Item
Schedule Visit 6 for 12 weeks (84 days± 7 days) after Visit 2. It is not necessary for the subject to be fasted.
text
C1709896 (UMLS CUI [1,1])
C2827036 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
Investigator Instructions
Item
Telephone the IVRS system to register the visit.
text
C1442085 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1,1])
C2585491 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
Collection Date
Item
Date samples taken
date
C1317250 (UMLS CUI [1])
Concomitant Medications
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Adverse Events
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs.
text
C0031809 (UMLS CUI [1])
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
CL Item
<1 mm (0)
CL Item
1 - 2 mm (1)
CL Item
3- 5 mm (2)
CL Item
6 - 10 mm (3)
CL Item
> 10 mm (4)
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)