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])
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])
Item
Race
text
C0034510 (UMLS CUI [1])
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)
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?
Item
Parent/sibling/child
text
C1517194 (UMLS CUI [1])
Code List
Parent/sibling/child
Item
Other relative
text
C3174795 (UMLS CUI [1])
Education History
Item
How many full years of education did the subject complete?
text
C0013658 (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
Estimated Depth of Indentation
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Code List
Estimated Depth of Indentation
Item
Which ankle was assessed at this visit
integer
C0574002 (UMLS CUI [1])
Code List
Which ankle was assessed at this visit
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
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])
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
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])
Item
Route
text
C0013153 (UMLS CUI [1])
CL Item
lntramuscular (IM)
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
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
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])
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])
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])
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])