Clinical trial: A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease (NCT03765762)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's
             Association (NIA-AA) Criteria

          -  MMSE Score 0-10 inclusive

          -  Modified Hachinski Ischemia Scale (MHIS) score of 4 or less

          -  Provided a signed and dated informed consent form (either the subject and/or subject's
             legal representative)

        Exclusion Criteria:

          -  Evidence of clinically relevant neurological disorder(s) other than probable AD

          -  History of blood coagulation disorders or hypercoagulability; any concurrent use of an
             anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
             inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

          -  Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable
             angina in the 6 months prior to dosing.

          -  Moderate to severe congestive heart failure (New York Association Class III or IV).

          -  Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher
             and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3
             months prior to dosing, or treatment refractory high blood pressure, defined as
             treatment requiring 3 or more antihypertensives from different classes.

          -  Prior hypersensitivity reaction to any human blood product or intravenous infusion;
             any known clinically significant drug allergy.

          -  Treatment with any human blood product, including transfusions and intravenous
             immunoglobulin, during the 6 months prior to screening.

          -  History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
             anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

          -  Hemoglobin <10 g/dL in women; and <11 g/dL in men.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 95 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? 1