Clinical trial: A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease (NCT03019536)

Eligibility criteria:
Inclusion Criteria:

          -  Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD
             based on National Institute of Aging and Alzheimer's Association diagnostic criteria

          -  Female participants: women not of child-bearing potential may participate, and include
             those who are:

               -  Infertile due to surgical sterilisation (hysterectomy, bilateral oophorectomy, or
                  for countries outside of Japan, tubal ligation), congenital anomaly such as
                  mullerian agenesis; or

               -  Postmenopausal defined as women at least 50 years of age with an intact uterus
                  who have not taken hormones or oral contraceptives within 1 year, who have had
                  either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous
                  amenorrhea with follicle-stimulating greater than (>) 40 milli-international
                  units per millilitre (mIU/mL)

          -  Have a body weight of at least 50 kilogram (kg) (except for Japanese sites) and have a
             body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (kg/m²) (for all
             sites), inclusive, at screening

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product (IP)
             or any other type of medical research judged not to be scientifically or medically
             compatible with this study

          -  Have participated, within the last 30 days (3 months and 4 months for sites in the
             European Union [EU] and Japan, respectively) in a clinical trial involving an IP. If
             the previous IP has a long half-life, 3 months (4 months for sites in Japan) or 5
             half-lives (whichever is longer) should have passed

          -  Have known allergies to LY3303560, related compounds or any components of the
             formulation, or history of significant atopy

          -  Have significant allergies to humanised monoclonal antibodies, diphenhydramine,
             adrenaline, or methylprednisolone; or have a history of clinically significant
             multiple or severe drug allergies, or intolerance to topical corticosteroids, or
             severe post treatment hypersensitivity reactions (including, but not limited to,
             erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal
             necrolysis, or exfoliative dermatitis)

          -  Have an increased risk of seizures as evidenced by a history of head trauma with loss
             of consciousness within the last 5 years or any seizure; prior electroencephalogram
             with epileptiform activity; surgery to the cerebral cortex; or history within the last
             5 years of a serious infectious disease affecting the brain

          -  Have any contraindications for Magnetic Resonance Imaging (MRI) studies, including
             claustrophobia, or the presence of metal (ferromagnetic) implants or a cardiac
             pacemaker

          -  Have a history of intracranial haemorrhage, cerebrovascular aneurysm, or arteriovenous
             malformation, carotid artery occlusion, or epilepsy

          -  Have received acetylcholinesterase inhibitors (AChEIs), memantine, and/or other AD
             therapy for less than 4 weeks, or have less than 4 weeks of stable therapy on these
             treatments by time of randomisation (including less than 4 weeks since stopping AChEIs
             and/or memantine); or have received medications that affect the central nervous
             system, except treatments for AD, for less than 4 weeks at a stable dose

          -  Have used stable medical therapy for less than 2 months by time of randomization for
             any concurrent medical condition that is not exclusionary

          -  Are currently using or intend to use drugs known to significantly prolong the QT
             interval, or who have a known risk factor for Torsades de Pointes. A participant will
             not be excluded if they have been using stable medication that is known to potentially
             cause significant prolongation of the QT interval, but does not present with any
             clinically significant prolongation of the QT interval at screening, in the opinion of
             the investigator

          -  History of cancer within the last 5 years, with the exception of non-metastatic basal
             and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive
             prostate cancer, or other cancers with low risk of recurrence or spread.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


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