At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 148 enrolled
Drug / intervention
Donanemab +1 moredrug
Likely dose
Donanemab 700 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Donanemab and Aducanumab for Mild Cognitive Impairment (MCI) and Alzheimer Disease. Completed, enrolled 148 participants across 31 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment (MCI), Alzheimer Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedNov 2021
Enrollment StartNov 2021
Primary CompletionSep 2022
Study CompletionSep 2023
TodayJul 2026
First PostedNov 5, 2021
Enrollment StartNov 16, 2021
Primary CompletionSep 9, 2022
Study CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago
Interventions
Donanemabdrug
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.
Aducanumabdrug
Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).