This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72 participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination \[MMSE\] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered after the completion of initial double-blind stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
77
Participants will receive crenezumb dose level 1 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
Participants will receive crenezumb dose level 2 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
Participants will receive crenezumb dose level 3 IV infusion once every 4 weeks upto Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
Mayo Clinic Scottsdale
Phoenix, Arizona, United States
UCSF - Memory and Aging Center
San Francisco, California, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Number of participants with anti-crenezumab antibodies
Time frame: From baseline up to follow-up period (Week 69)
Number of participants with suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent, as determined using the columbia-cuicide severity rating scale (C-SSRS)
Time frame: From baseline up to follow-up period (Week 69)
Number of participants with changes from baseline in vital signs, electrocardiogram (ECG) and clinical laboratory results
Time frame: From baseline up to follow-up period (Week 69)
Number of participants with amyloid-related imaging abnormalities-hemorrhage (ARIA-H)
Time frame: Up to Week 13
Number of participants with adverse events (AEs) and serious adverse events (SAEs) according to national cancer institute common terminology criteria for adverse events, version 4.0 (NCICTCAE v4.0)
Time frame: From baseline up to follow-up period (Week 69)
Number of participants with of non-serious AEs of special interest
Time frame: From baseline up to follow-up period (Week 69)
Number of participants with amyloid-related imaging abnormalities-edema/effusion (ARIA-E)
Time frame: Up to Week 13
Serum concentration of crenezumab
Time frame: Pre-dose on Day 1, 60-90 minutes (min) post infusion on Day 1, Days 2, 8, Week 2, pre-dose and 60-90 min post infusion on dosing day of Weeks 5, 9, 13, and 21; pre-dose and 60-90 min post infusion on dosing day of Weeks 25, 53, 61, and 69
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Participants will receive placebo matched to crenezumab IV infusion once every 4 weeks upto Week 13 in double-blind treatment window.
Miami Jewish Health Systems
Miami, Florida, United States
Bioclinica Orlando
Orlando, Florida, United States
Bioclinica The Villages
The Villages, Florida, United States
Indiana University School Of Medicine; Department Of Neurology
Indianapolis, Indiana, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates, LLC
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
...and 3 more locations