Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below. INELIGIBLE SUBJECTS ONLY Telephone the IVRS system to report the subject as a screening failure.
Check the boxes corresponding to any of the inclusion criteria the subject failed.
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Male or female subject with a clinical diagnosis of probable Alzheimer´s disease in accordance with NINCDS-ADRDA criteria. (Subjects with a clinical diagnosis of possible Alzheimer´s disease are not eligible.) (1)
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Subject has mild to moderate Alzheimer´s disease with MMSE score 16-26 inclusive at screening. (2)
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Age <50 and >85 years. (3)
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Prior and current medication is in accordance with the criteria on facing page. (4)
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Female subject must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bering potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intrauterine 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. (5)
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CT or MRI scan performed within the past 12 months or at screening, showing no evidence of tumor, other structural abnormality, or degenerative disease other than Alzheimer´s disease. (6)
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Neurological exam without focal changes (excluding changes attributable to peripheral trauma). (7)
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Subject has the ability to comply with procedures for cognitive and other testing. (8)
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Subject lives with a permanent caregiver who is willing to attend all visits, oversee the subject´s compliance with protocol-specified procedures and study medication, an report on subject´s status. (Subject´s living alone or in a nursing home are not eligible) (9)
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Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative. (10)
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Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure. (11)
Check at the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
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History of Type 1 or Type 2 diabetes mellitus. (1)
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Fasting plasma glucose level >126mg/dL (>7.0mmol/L) or HbA1C >6.2%. (2)
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History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV). (3)
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Ejection fraction <40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page). (4)
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History of new cardiovascular event wishing 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 stunting) scheduled). (5)
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History or clinical laboratory evidence of cerebrovascular disease (Strke, transient ischemic attack, hemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria. (6)
A medically qualified Sub-investigator may sign this page; however, the Investigator remains accountable for CRF data.
text
C1442085 (UMLS CUI [1])
Invenstigator´s Signature
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I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.