At a glance
ClinicalIndex Comparison RecordPhase 3Active· 1,736 enrolled
Drug / intervention
Donanemab +1 moredrug
Likely dose
Not stated in 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.
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Donanemab and Placebo for Alzheimer Disease. Active but no longer recruiting, targeting 1,736 participants across 274 sites in 9 countries.
Detailed Summary
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesAustralia, Canada, Czechia, Japan, Netherlands, Poland, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
202120222023202420252026202720282029
First PostedJun 2020
Enrollment StartJun 2020
Primary CompletionApr 2023
TodayJul 2026
Study CompletionNov 2028
First PostedJun 18, 2020
Enrollment StartJun 19, 2020
Primary CompletionApr 14, 2023
Study CompletionNov 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.0 years ago
Interventions
Donanemabdrug
Given IV
Placebodrug
Given IV