This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled per addendum. The study will last approximately 91 weeks and include up to 26 visits in the main study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,175
MD First Research - Chandler
Chandler, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Healthy Brain Clinic
Long Beach, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
JEM Research Institute
Atlantis, Florida, United States
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
Time frame: 24 Weeks
Percentage of Participants With Any Occurrence of ARIA-E
Outcome data will be provided after the study is completed.
Time frame: 52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Outcome data will be provided after the study is completed.
Time frame: Baseline, 76 Weeks
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.
Time frame: 24 Weeks
Percentage of Participants With ARIA-H
Outcome data will be provided after the study is completed.
Time frame: 52 Weeks
Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H
Outcome data will be provided after the study is completed.
Time frame: 76 Weeks
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Outcome data will be provided after the study is completed.
Time frame: Baseline to 76 Weeks
Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies
Outcome data will be provided after the study is completed.
Time frame: Baseline to End of Follow-Up (91 Weeks)
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VIN-Julie Schwartzbard
Aventura, Florida, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
K2 Medical Research
Clermont, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
...and 39 more locations