A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Condition: Mild Cognitive Impairment (MCI); Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Donanemab; Aducanumab
Intervention description: Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W.; Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease with MCI or Mild Dementia

Summary:

      The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque
      clearance in participants with early symptomatic Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gradual and progressive change in memory function reported by the participant or
             informant for ≥6 months.

          -  Meet florbetapir F18 PET scan criteria.

          -  A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.

          -  Must consent to apolipoprotein E (ApoE) genotyping

          -  Must have a mini mental state examination (MMSE) score between 20 and 30

          -  Have a study partner who will provide written informed consent to participate, is in
             frequent contact with the participant (defined as at least 10 hours per week), and
             will accompany the participant to study visits or be available by telephone at
             designated times.

          -  Have adequate literacy, vision, and hearing for neuropsychological testing in the
             opinion of the investigator at the time of screening.

          -  Women not of childbearing potential may participate

        Exclusion Criteria:

          -  Significant neurological disease affecting the central nervous system (other than AD),
             that may affect cognition or ability to complete the study, including but not limited
             to, other dementias, serious infection of the brain, Parkinson's disease, multiple
             concussions, history of transient ischemic attack or stroke, or epilepsy or recurrent
             seizures (except febrile childhood seizures).

          -  Current serious or unstable medical illnesses including cardiovascular, hepatic,
             renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively
             suicidal or deemed at risk of suicide, or current alcohol or substance abuse),
             immunologic, infectious, or hematologic disease and other conditions that, in the
             investigator's opinion, could interfere with the analyses in this study; or has a life
             expectancy of approximately

             ≤24 months.

          -  History of clinically significant multiple or severe drug allergies, or severe
             posttreatment hypersensitivity reactions (including but not limited to erythema
             multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis,
             and/or exfoliative dermatitis).

          -  History of bleeding disorder or use of medications with platelet anti-aggregant or
             anti-coagulant properties (unless aspirin at ≤325 milligram (mg).

          -  Have had prior or current treatment with donanemab or aducanumab

          -  Have known allergies to donanemab or aducanumab, related compounds, or any components
             of the formulation

          -  Prior or current participation in any immunotherapy study targeting Amyloid beta