Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
Arabic/North Africa (1)
CL Item
East & South East Asian (3)
CL Item
White/Caucasian (6)
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])
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])
Code List
Depth of Indentation
Item
Check the appropriate box below to indicate which ankle was assessed at this visit.
integer
C0003086 (UMLS CUI [1])
Code List
Check the appropriate box below to indicate which ankle was assessed at this visit.
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])
Code List
What is the subject´s history of tobacco use (includes all tobacco products)?
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])
Code List
Condition status
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])
Code List
Result of the ECG
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])