Clinical trial: A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease (NCT02880956)

Eligibility criteria:
Inclusion Criteria:

          -  Subject who meets the National Institute on Aging and the Alzheimer's Association
             (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

               -  Clinical Dementia Rating (CDR)-Global Score of 0.5

               -  Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive

               -  Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory
                  Index (RBANS - DMI) score of 85 or lower

          -  Subject has a positive amyloid Positron Emission Tomography (PET) scan.

          -  Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.

          -  The subject has an identified, reliable, study partner (e.g., family member).

          -  If using medications to treat symptoms related to AD, doses must be stable for at
             least 12 weeks prior to randomization.

        Exclusion Criteria:

          -  Subject has any contraindications or inability to tolerate brain magnetic resonance
             imaging (MRI), PET scans or lumbar puncture.

          -  Subject has evidence of any other clinically significant neurological disorder other
             than Early AD.

          -  In the opinion of the investigator, the subject has any clinically significant or
             uncontrolled medical or psychiatric illness, or has had an infection requiring medical
             intervention in the past 30 days.

          -  Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
             attack or required intervention for any of these conditions within 6 months of
             Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 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