A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer’s Disease
– 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.
– 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
- Irvine Clinical Research /ID# 162331, Irvine, California, United States, 92614
- Ucsd /Id# 152467, La Jolla, California, United States, 92037
- Ray Dolby Brain Health Center /ID# 154965, San Francisco, California, United States, 94113
- Univ California, San Francisco /ID# 152053, San Francisco, California, United States, 94143-2204