ID

25793

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

  1. 9/20/17 9/20/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Glaxo Smith Klyne

Uploaded on

September 20, 2017

DOI

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License

Creative Commons BY-NC 3.0

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GSK AVA100193 Rosiglitazone in Alzheimer´s Disease - Screening Visit

Screening Visit

  1. StudyEvent: ODM
    1. Screening Visit
Neuropsychological Tests
Description

Neuropsychological Tests

Alias
UMLS CUI-1
C0027902
Mini Mental State Examination
Description

Mini Mental State Examination

Data type

text

Alias
UMLS CUI [1]
C0451306
Hospital Anxiety and Depression scale
Description

HADS

Data type

text

Alias
UMLS CUI [1]
C3539657
Alzheimer's Disease Assessment Scale
Description

Alzheimer's Disease Assessment Scale

Data type

text

Alias
UMLS CUI [1]
C0450989
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre or investigator number
Description

Centre or investigator number

Data type

integer

Alias
UMLS CUI [1]
C2826689
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Alzheimers disease diagnosis and course
Description

Alzheimers disease diagnosis and course

Alias
UMLS CUI-1
C0002395
UMLS CUI-2
C0011900
UMLS CUI-3
C0449259
Date of first symptoms
Description

Date of first symptoms

Data type

date

Alias
UMLS CUI [1]
C0574845
Date of diagnosis of probable AD
Description

Date of diagnosis of probable AD

Data type

date

Alias
UMLS CUI [1,1]
C0332148
UMLS CUI [1,2]
C0011008
Has there been a significant worsening in the past 6 months?
Description

Significant worsening

Data type

boolean

Alias
UMLS CUI [1]
C0332271
Is there any family history of AD?
Description

family history of AD

Data type

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0002395
Parent/sibling/child
Description

First degree relative

Data type

text

Alias
UMLS CUI [1]
C1517194
Other relative
Description

Other relative

Data type

text

Alias
UMLS CUI [1]
C3174795
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Patient Height
Description

Height

Data type

integer

Alias
UMLS CUI [1]
C0489786
Patient Weight
Description

Weight

Data type

integer

Alias
UMLS CUI [1]
C0005910
Systolic blood pressure
Description

Blood pressure

Data type

integer

Alias
UMLS CUI [1]
C0871470
Diastolic blood pressure
Description

Blood pressure

Data type

integer

Alias
UMLS CUI [1]
C0428883
Heart rate
Description

Heart rate

Data type

integer

Alias
UMLS CUI [1]
C0018810
Education History
Description

Education History

Alias
UMLS CUI-1
C0013622
How many full years of education did the subject complete?
Description

Education History

Data type

text

Alias
UMLS CUI [1]
C0013658
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
Gait assessment
Description

Gait assessment

Data type

text

Alias
UMLS CUI [1]
C2459822
Balance assessment
Description

Balance assessment

Data type

text

Alias
UMLS CUI [1]
C0560184
Coordination
Description

Coordination

Data type

text

Alias
UMLS CUI [1]
C0242414
Cranial nerves
Description

Cranial nerves

Data type

text

Alias
UMLS CUI [1]
C0010268
Motor system
Description

Motor system

Data type

text

Alias
UMLS CUI [1]
C0026606
Sensory system
Description

Sensory system

Data type

text

Alias
UMLS CUI [1,1]
C0682648
UMLS CUI [1,2]
C0031809
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Pedal Edema
Description

Pedal Edema

Alias
UMLS CUI-1
C0013604
Estimated 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.

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Which ankle was assessed at this visit
Description

Pedal edema

Data type

integer

Alias
UMLS CUI [1]
C0574002
Tobacco use
Description

Tobacco use

Alias
UMLS CUI-1
C0038586
UMLS CUI-2
C0543414
What is the subject's history of tobacco use ?
Description

includes all tobacco products

Data type

integer

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0841002
When did the subject last smoke?
Description

Former smoker

Data type

date

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C4288952
Number of cigarettes smoked per day?
Description

If current or former smoker, answer the following questions

Data type

integer

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C1519386
Number of years during which the subject has smoked?
Description

If current or former smoker, answer the following questions

Data type

integer

Measurement units
  • yrs
Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C1519386
yrs
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0009488
Specific Condition
Description

Medical condition

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009488
Please specify condition status
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.

Data type

integer

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3176928
Concomitant Medication
Description

Concomitant Medication

Drug Name
Description

Medication Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
Units
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Route
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

i.e "Headache"

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Start date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Stop date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing Medication
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
Screening summary
Description

Screening summary

Alias
UMLS CUI-1
C1710032
UMLS CUI-2
C0242482
Date samples taken
Description

Collection date fasting samples

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C2348510
Pregnancy test
Description

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Data type

text

Alias
UMLS CUI [1]
C0032976
Date of ECG
Description

Date of 12 lead ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2584899
Result of the ECG
Description

ECG result

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
If ECG clinically significant abnormal ,assess eligibility (exclusion criterion 4) and record abnormalities on the medical conditions page.
Description

ECG result

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Depression score
Description

Note: A score of 0-7 is required for a subject to be eligible for this study

Data type

integer

Alias
UMLS CUI [1]
C3539657
MMSE Score
Description

Note: A score of 16-26 is required for a subject to be eligible for this study

Data type

integer

Alias
UMLS CUI [1]
C0451306
Review the eligibility criteria which you have been able to assess at this visit. Where the subject is ineligible, document this, and the criterion/criteria on which they failed, on the Inclusion/Exclusion criteria pages. Where the patient appears to be eligible at this point, perform an ADAS-cog assessment.
Description

Eligibility Assessment

Data type

text

Alias
UMLS CUI [1]
C0013893
Alzheimer's Disease Assessment Scale
Description

Alzheimer's Disease Assessment Scale

Data type

text

Alias
UMLS CUI [1]
C0450989
Refer the subject for the following procedures (results to be available prior to Visit 2). Echocardiogram Chest X-ray (not required where a chest X-ray has been performed within the previous 3 months and the report is available to the investigator). CT scan (not required where a CT or MRI scan has been performed within the previous 12 months and the report is available to the investigator). Schedule Visit 2 for 14 days( 7 days) after Visit 1, 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).
Description

Investigator instruction

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
Ejection fraction
Description

Note: If any abnormalities are found as a result of the echocardiogram, these must be recorded on the medical conditions page.

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C2243117
UMLS CUI [1,2]
C2700377
%
Assess the subject's eligibility on the basis of information which has become available since the screening visit (echocardiogram, plus laboratory results, CT scan and chest X-ray where applicable). Where the subject is ineligible, document this, and the criterion/criteria on which they failed, on the Inclusion/ Exclusion criteria pages. No further assessments should be performed. Where the subject is eligible, document this on the Inclusion/Exclusion criteria page, and proceed to the next CRF book.
Description

Eligibility Assessment

Data type

text

Alias
UMLS CUI [1]
C0013893
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C1512693
Did the subject meet all the entry criteria?
Description

Eligibility

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA4 criteria
Description

(Subjects with a clinical diagnosis of possible Alzheimer's disease are not eligible).

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0002395
Subject has mild to moderate Alzheimer's disease with MMSE score 16-26 inclusive at screening.
Description

mild to moderate Alzheimer's disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0451306
Age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Prior and current medication is in accordance with the criteria on facing page.
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to screening, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
Description

Post-menopausal or if of childbearing potential use effective contraceptive method

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
CT or MRI scan performed within the past 12 months or at screening, showing no evidence of tumour, other structural abnormality, or degenerative disease other than Alzneimer's disease.
Description

CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease

Data type

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
Neurological exam without focal changes (excluding changes attributable to peripheral trauma).
Description

Neurological exam without focal changes

Data type

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0239622
UMLS CUI [1,3]
C0332197
Subject has the ability to comply with procedures for cognitive and other testing.
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
Description

Caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure.
Description

Caregiver informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C0021430
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
History of Type 1 or Type 2 diabetes mellitus.
Description

Diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Fasting plasma glucose level >126 mg/dL (>7.0 mmol/L) or Hb 0 >6.2 percent.
Description

Fasting plasma glucose measurement and Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0518015
History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV).
Description

congestive heart failure New York Heart Association criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
Ejection fraction smaller or equal to 40 percent determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page).
Description

Ejection fraction measurement, ECG abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C2020641
UMLS CUI [2]
C1832603
History of new cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
Description

Medical history of cardiovascular event,significant arrhythmia or major intervention

Data type

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
Diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria
Description

vascular dementia

Data type

boolean

Alias
UMLS CUI [1]
C0011269
History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, transient ischemic attack, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
Description

history or evidence of CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0455508
History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, that in the opinion of the investigator would interfere with participation in the study, or current depression
Description

(score on Hospital Anxiety and Depression Scale (HADS) depression questions >7) (See Protocol Appendix 11)

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004936
Significant peripheral edema at the time of screening.
Description

peripheral edema

Data type

boolean

Alias
UMLS CUI [1]
C0085649
Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg whilst receiving optimal antihypertensive therapy according to local practice.
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
Clinically significant anemia (i.e. hemoglobin <11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
Description

Renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3279454
ALT, AST, total bilirubin or alkaline phosphatase values >2.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis).
Description

Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
Fasting triglycerides >12 mmol/L.
Description

Fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
Abnormal/positive result within the past 12 months or at screening for any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH), where this is thought to be the cause of, or to contribute to the severity of, the subjects dementia.
Description

Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone

Data type

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
History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Description

Eligibility Determination, other relevant conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0036464
Subject has given a blood donation of :2450 ml within the past 2 months.
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
History of drug or alcohol abuse.
Description

Substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study, has a history of non-compliance with prescribed medication, or is at risk of non-compliance with study medication or procedures.
Description

Compliance behavior limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Subject is an immediate family member or employee of the participating investigator or of any of the participating site staff.
Description

Family member of research personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0086282
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of completion
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287

Similar models

Screening Visit

  1. StudyEvent: ODM
    1. Screening Visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Neuropsychological Tests
C0027902 (UMLS CUI-1)
Mini Mental State Examination
Item
Mini Mental State Examination
text
C0451306 (UMLS CUI [1])
HADS
Item
Hospital Anxiety and Depression scale
text
C3539657 (UMLS CUI [1])
Alzheimer's Disease Assessment Scale
Item
Alzheimer's Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre or investigator number
Item
Centre or investigator number
integer
C2826689 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Female (F)
CL Item
Male (M)
Item
Race
text
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
Arabic/North African (2)
(Comment:en)
CL Item
Black (3)
(Comment:en)
CL Item
East and South East Asian (4)
(Comment:en)
CL Item
Japanese (5)
(Comment:en)
CL Item
South Asian (6)
(Comment:en)
CL Item
White /Caucasian (7)
(Comment:en)
CL Item
other (Z)
(Comment:en)
Item Group
Alzheimers disease diagnosis and course
C0002395 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
C0449259 (UMLS CUI-3)
Date of first symptoms
Item
Date of first symptoms
date
C0574845 (UMLS CUI [1])
Date of diagnosis of probable AD
Item
Date of diagnosis of probable AD
date
C0332148 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Significant worsening
Item
Has there been a significant worsening in the past 6 months?
boolean
C0332271 (UMLS CUI [1])
Item
Is there any family history of AD?
text
C0241889 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
Code List
Is there any family history of AD?
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown (U)
Item
Parent/sibling/child
text
C1517194 (UMLS CUI [1])
Code List
Parent/sibling/child
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown (U)
Item
Other relative
text
C3174795 (UMLS CUI [1])
Code List
Other relative
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown (U)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Patient Height
integer
C0489786 (UMLS CUI [1])
Weight
Item
Patient Weight
integer
C0005910 (UMLS CUI [1])
Blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Education History
C0013622 (UMLS CUI-1)
Education History
Item
How many full years of education did the subject complete?
text
C0013658 (UMLS CUI [1])
Item Group
Neurological Examination
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])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Edema
C0013604 (UMLS CUI-1)
Item
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Code List
Estimated Depth of Indentation
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)
Item
Which ankle was assessed at this visit
integer
C0574002 (UMLS CUI [1])
Code List
Which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Tobacco use
C0038586 (UMLS CUI-1)
C0543414 (UMLS CUI-2)
Item
What is the subject's history of tobacco use ?
integer
C0038586 (UMLS CUI [1,1])
C0841002 (UMLS CUI [1,2])
Code List
What is the subject's history of tobacco use ?
CL Item
Never smoked  (1)
CL Item
Current smoker  (2)
CL Item
Former smoker (specify) (3)
Former smoker
Item
When did the subject last smoke?
date
C0038586 (UMLS CUI [1,1])
C4288952 (UMLS CUI [1,2])
Current or former smoker
Item
Number of cigarettes smoked per day?
integer
C0038586 (UMLS CUI [1,1])
C1519386 (UMLS CUI [1,2])
Current or former smoker
Item
Number of years during which the subject has smoked?
integer
C0038586 (UMLS CUI [1,1])
C1519386 (UMLS CUI [1,2])
Item Group
Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
Medical condition
Item
Specific Condition
text
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Item
Please specify condition status
integer
C0009488 (UMLS CUI [1,1])
C3176928 (UMLS CUI [1,2])
Code List
Please specify condition status
CL Item
Current  (1)
CL Item
Past (2)
Item Group
Concomitant Medication
Medication Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Route
text
C0013153 (UMLS CUI [1])
CL Item
lntramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Medical indication for pharmaceutical agent
Item
Reason for Medication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date of medication
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of medication
Item
Stop date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Code List
Ongoing Medication
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Screening summary
C1710032 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Collection date fasting samples
Item
Date samples taken
date
C1302413 (UMLS CUI [1,1])
C2348510 (UMLS CUI [1,2])
Pregnancy test
Item
Pregnancy test
text
C0032976 (UMLS CUI [1])
Date of 12 lead ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of the ECG
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 ,assess eligibility (exclusion criterion 4) and record abnormalities on the medical conditions page.
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HADS Summary
Item
Depression score
integer
C3539657 (UMLS CUI [1])
MMSE Summary
Item
MMSE Score
integer
C0451306 (UMLS CUI [1])
Eligibility Assessment
Item
Review the eligibility criteria which you have been able to assess at this visit. Where the subject is ineligible, document this, and the criterion/criteria on which they failed, on the Inclusion/Exclusion criteria pages. Where the patient appears to be eligible at this point, perform an ADAS-cog assessment.
text
C0013893 (UMLS CUI [1])
Alzheimer's Disease Assessment Scale
Item
Alzheimer's Disease Assessment Scale
text
C0450989 (UMLS CUI [1])
Investigator instruction
Item
Refer the subject for the following procedures (results to be available prior to Visit 2). Echocardiogram Chest X-ray (not required where a chest X-ray has been performed within the previous 3 months and the report is available to the investigator). CT scan (not required where a CT or MRI scan has been performed within the previous 12 months and the report is available to the investigator). Schedule Visit 2 for 14 days( 7 days) after Visit 1, 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
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Echocardiogram ejection fraction
Item
Ejection fraction
integer
C2243117 (UMLS CUI [1,1])
C2700377 (UMLS CUI [1,2])
Eligibility Assessment
Item
Assess the subject's eligibility on the basis of information which has become available since the screening visit (echocardiogram, plus laboratory results, CT scan and chest X-ray where applicable). Where the subject is ineligible, document this, and the criterion/criteria on which they failed, on the Inclusion/ Exclusion criteria pages. No further assessments should be performed. Where the subject is eligible, document this on the Inclusion/Exclusion criteria page, and proceed to the next CRF book.
text
C0013893 (UMLS CUI [1])
Item Group
Inclusion criteria
C1516637 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
Eligibility
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
clinical diagnosis Alzheimer's disease
Item
Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA4 criteria
boolean
C0011900 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
mild to moderate Alzheimer's disease
Item
Subject has mild to moderate Alzheimer's disease with MMSE score 16-26 inclusive at screening.
boolean
C0002395 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Age
Item
Age
boolean
C0001779 (UMLS CUI [1])
Concomitant medication
Item
Prior and current medication is in accordance with the criteria on facing page.
boolean
C2347852 (UMLS CUI [1])
Post-menopausal or if of childbearing potential use effective contraceptive method
Item
Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to screening, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
CT or MRI scan shows no evidence of tumor or structural abnormality or degenerative disease other than Alzheimers disease
Item
CT or MRI scan performed within the past 12 months or at screening, showing no evidence of tumour, other structural abnormality, or degenerative disease other than Alzneimer's disease.
boolean
C0006118 (UMLS CUI [1,1])
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])
Neurological exam without focal changes
Item
Neurological exam without focal changes (excluding changes attributable to peripheral trauma).
boolean
C0027853 (UMLS CUI [1,1])
C0239622 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Compliance behavior
Item
Subject has the ability to comply with procedures for cognitive and other testing.
boolean
C1321605 (UMLS CUI [1])
Caregiver
Item
Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
boolean
C0085537 (UMLS CUI [1])
Caregiver informed consent
Item
Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure.
boolean
C0085537 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Diabetes mellitus
Item
History of Type 1 or Type 2 diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Fasting plasma glucose measurement and Hemoglobin measurement
Item
Fasting plasma glucose level >126 mg/dL (>7.0 mmol/L) or Hb 0 >6.2 percent.
boolean
C0583513 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
congestive heart failure New York Heart Association criteria
Item
History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV).
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Ejection fraction measurement, ECG abnormalities
Item
Ejection fraction smaller or equal to 40 percent determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page).
boolean
C2020641 (UMLS CUI [1])
C1832603 (UMLS CUI [2])
Medical history of cardiovascular event,significant arrhythmia or major intervention
Item
History of new cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
boolean
C0262926 (UMLS CUI [1,1])
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])
vascular dementia
Item
Diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria
boolean
C0011269 (UMLS CUI [1])
history or evidence of CNS disorder
Item
History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, transient ischemic attack, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
boolean
C0455508 (UMLS CUI [1])
History of psychiatric illness
Item
History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, that in the opinion of the investigator would interfere with participation in the study, or current depression
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
peripheral edema
Item
Significant peripheral edema at the time of screening.
boolean
C0085649 (UMLS CUI [1])
Hypertensive disease
Item
Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg whilst receiving optimal antihypertensive therapy according to local practice.
boolean
C0020538 (UMLS CUI [1])
Anemia
Item
Clinically significant anemia (i.e. hemoglobin <11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA
boolean
C0002871 (UMLS CUI [1])
Renal dysfunction
Item
Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
boolean
C3279454 (UMLS CUI [1])
Liver diseases
Item
ALT, AST, total bilirubin or alkaline phosphatase values >2.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis).
boolean
C0023895 (UMLS CUI [1])
Fasting triglyceride measurement
Item
Fasting triglycerides >12 mmol/L.
boolean
C0582824 (UMLS CUI [1])
Laboratory testing vitamin B12, syphilis serology, thyroid stimulating hormone
Item
Abnormal/positive result within the past 12 months or at screening for any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH), where this is thought to be the cause of, or to contribute to the severity of, the subjects dementia.
boolean
C0022885 (UMLS CUI [1,1])
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])
Eligibility Determination, other relevant conditions
Item
History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
boolean
C0013893 (UMLS CUI [1,1])
C0036464 (UMLS CUI [1,2])
Blood Donation
Item
Subject has given a blood donation of :2450 ml within the past 2 months.
boolean
C0005794 (UMLS CUI [1])
Substance use disorder
Item
History of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Compliance behavior limited
Item
Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study, has a history of non-compliance with prescribed medication, or is at risk of non-compliance with study medication or procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Family member of research personnel
Item
Subject is an immediate family member or employee of the participating investigator or of any of the participating site staff.
boolean
C0035173 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date of completion
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])

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