ID

21023

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. Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100193, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1

Keywords

Versions (1)
  1. 4/3/17 4/3/17 -
Uploaded on

April 3, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193

English

Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193

1 forms  
Investigator Instructions
Description

Investigator Instructions

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1442085
Telephone the Interactive Voice Response System (IVRS) to register the subject.
Description

Subject registry

Data type

text

Alias
UMLS CUI [1]
C0034975
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Alzheimer´s disease diagnosis and course
Description

Alzheimer´s disease diagnosis and course

Alias
UMLS CUI-1
C0002395
UMLS CUI-2
C0011900
UMLS CUI-3
C0750729
Date of first symptoms
Description

Date of first symptoms

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0449990
Date of diagnosis of probable AD
Description

Date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
Has there been a significant worsening in the past 6 months?
Description

Worsening

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1442792
Is there any family history of AD?
Description

family history

Data type

integer

Alias
UMLS CUI [1]
C0241889
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Body
Description

Body Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood Pressure. (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.)
Description

Diastolic blood pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Heart Rate

Data type

float

Measurement units
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Education History
Description

Education History

Alias
UMLS CUI-1
C0013622
How many full years of education did the subject complete? (include primary to post-university education)
Description

Years of education

Data type

float

Measurement units
  • yrs
Alias
UMLS CUI [1]
C0013658
yrs
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
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 neurological examination, these must be recorded on the Medical Conditions page.
Description

Neurological findings

Data type

text

Alias
UMLS CUI [1]
C0437208
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the neurological examination, these must be recorded on the Medical Conditions page.
Description

physical examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [2]
C0018793
UMLS CUI [3]
C2230255
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Depth of Indentation
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. Note: Use the same ankle throughout the study.

Data type

integer

Alias
UMLS CUI [1]
C2081478
Check the appropriate box below to indicate which ankle was assessed at this visit.
Description

Ankle

Data type

integer

Alias
UMLS CUI [1]
C0003086
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject´s history of tobacco use (includes all tobacco products)?
Description

Tobacco Use

Data type

integer

Alias
UMLS CUI [1]
C0543414
When did the subject last smoke?
Description

Last Smoked

Data type

date

Alias
UMLS CUI [1]
C3172719
Number of cigarettes smoked per day?
Description

If current or former smoker, answer the following questions:

Data type

float

Measurement units
  • per day
Alias
UMLS CUI [1]
C1608325
per day
Number of years during which the subject has smoked?
Description

If current or former smoker, answer the following questions:

Data type

float

Measurement units
  • years
Alias
UMLS CUI [1]
C1277691
years
Medical conditions
Description

Medical conditions

Alias
UMLS CUI-1
C0205476
UMLS CUI-2
C0348080
Specific Condition
Description

Record only one per line for each condition and check only one response for each condition.

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Condition status
Description

Condition status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Prior and Concomitant Medications
Description

Prior and Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2826257
Were any concomitant medications taken by the subject within 60 days prior to the study? If yes, record each medication on a separate line using Trade Names where possible.
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Prior And Concomitant Medications
Description

Prior And Concomitant Medications

Alias
UMLS CUI-1
C2347852
UMLS CUI-3
C2826257
Drug name (e.g. Aspirin)
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose (e.g. 400)
Description

total daily dose

Data type

float

Alias
UMLS CUI [1]
C2348070
Units (e.g. mg)
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Route (e.g. PO)
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication (e.g. Headache)
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date (e.g. 31 May 02)
Description

Start date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0808070
Day Month Year
Stop Date (e.g. 31 May 02)
Description

Stop Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0806020
Day Month Year
Ongoing Medication?
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Central Laboratory (Fasting Samples)
Description

Central Laboratory (Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C2826640
Day Month Year
Result of the ECG
Description

ECG Finding

Data type

text

Alias
UMLS CUI [1]
C0438154
HADS Summary
Description

HADS Summary

Alias
UMLS CUI-1
C3539657
Depression score Note: A score of 0-7 is required for a subject to be eligible for this study.
Description

Depression score

Data type

float

Alias
UMLS CUI [1]
C3539657
MMSE Summary
Description

MMSE Summary

Alias
UMLS CUI-1
C0451306
MMSE Score Note: A score of 16-26 is required for a subject to be eligible for this study.
Description

MMSE Score

Data type

float

Alias
UMLS CUI [1]
C2225229
Echocardiogram
Description

Echocardiogram

Alias
UMLS CUI-1
C2243117
Ejection fraction Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
Description

Ejection fraction

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0232174
%
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Similar models

Screening Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigator Instructions
C0008961 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Subject registry
Item
Telephone the Interactive Voice Response System (IVRS) to register the subject.
text
C0034975 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Arabic/North Africa (1)
CL Item
Black (2)
CL Item
East & South East Asian (3)
CL Item
Japanese (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Item Group
Alzheimer´s disease diagnosis and course
C0002395 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0750729 (UMLS CUI-3)
Date of first symptoms
Item
Date of first symptoms
date
C2316983 (UMLS CUI [1,1])
C0449990 (UMLS CUI [1,2])
Date of diagnosis
Item
Date of diagnosis of probable AD
date
C2316983 (UMLS CUI [1])
Worsening
Item
Has there been a significant worsening in the past 6 months?
boolean
C0012634 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
Item
Is there any family history of AD?
integer
C0241889 (UMLS CUI [1])
family history
Code List
Is there any family history of AD?
CL Item
Yes (Parent/sibling/child) (1)
CL Item
No (Parent/sibling/child) (2)
CL Item
Unknown (Parent/sibling/child) (3)
CL Item
Yes (Other relative) (4)
CL Item
No (Other relative) (5)
CL Item
Unknown (Other relative) (6)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Body Height
Item
Body
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure. (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.)
float
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart rate (Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.) Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0018810 (UMLS CUI [1])
Item Group
Education History
C0013622 (UMLS CUI-1)
Years of education
Item
How many full years of education did the subject complete? (include primary to post-university education)
float
C0013658 (UMLS CUI [1])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Neurological findings
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 neurological examination, these must be recorded on the Medical Conditions page.
text
C0437208 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (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 neurological examination, these must be recorded on the Medical Conditions page.
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0018793 (UMLS CUI [2])
C2230255 (UMLS CUI [3])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Depth of Indentation
integer
C2081478 (UMLS CUI [1])
Depth of Indentation
Code List
Depth of Indentation
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Check the appropriate box below to indicate which ankle was assessed at this visit.
integer
C0003086 (UMLS CUI [1])
Ankle
Code List
Check the appropriate box below to indicate which ankle was assessed at this visit.
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject´s history of tobacco use (includes all tobacco products)?
integer
C0543414 (UMLS CUI [1])
Tobacco Use
Code List
What is the subject´s history of tobacco use (includes all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Last Smoked
Item
When did the subject last smoke?
date
C3172719 (UMLS CUI [1])
Number of cigarettes
Item
Number of cigarettes smoked per day?
float
C1608325 (UMLS CUI [1])
Smoking
Item
Number of years during which the subject has smoked?
float
C1277691 (UMLS CUI [1])
Item Group
Medical conditions
C0205476 (UMLS CUI-1)
C0348080 (UMLS CUI-2)
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Condition status
integer
C3176928 (UMLS CUI [1])
Condition status
Code List
Condition status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Prior and Concomitant Medications
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
Concomitant Medication
Item
Were any concomitant medications taken by the subject within 60 days prior to the study? If yes, record each medication on a separate line using Trade Names where possible.
boolean
C2347852 (UMLS CUI [1])
Item Group
Prior And Concomitant Medications
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-3)
Drug name
Item
Drug name (e.g. Aspirin)
text
C0013227 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose (e.g. 400)
float
C2348070 (UMLS CUI [1])
Units
Item
Units (e.g. mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g. PO)
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication (e.g. Headache)
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start Date (e.g. 31 May 02)
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date (e.g. 31 May 02)
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Item Group
Central Laboratory (Fasting Samples)
C1880016 (UMLS CUI-1)
Date sample taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
ECG Finding
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Assess eligibility (exclusion criterion 4) and record abnormalities within the medical conditions item) (3)
Item Group
HADS Summary
C3539657 (UMLS CUI-1)
Depression score
Item
Depression score Note: A score of 0-7 is required for a subject to be eligible for this study.
float
C3539657 (UMLS CUI [1])
Item Group
MMSE Summary
C0451306 (UMLS CUI-1)
MMSE Score
Item
MMSE Score Note: A score of 16-26 is required for a subject to be eligible for this study.
float
C2225229 (UMLS CUI [1])
Item Group
Echocardiogram
C2243117 (UMLS CUI-1)
Ejection fraction
Item
Ejection fraction Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.
float
C0232174 (UMLS CUI [1])
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