CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,175 enrolled
Drug / intervention
Donanemab +2 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.

Search/NCT05738486
NCT05738486Phase 3Active

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Eli Lilly and Company·interventional·Posted Feb 22, 2023·Updated Jun 18, 2026

In Brief

A Phase 3 clinical trial evaluating Donanemab, Placebo, and 1 other intervention for Alzheimer's Disease and 7 related conditions. Active but no longer recruiting, targeting 1,175 participants across 49 sites in 2 countries.

Detailed Summary

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 in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 3Active
2024202520262027
First PostedFeb 22, 2023
Enrollment StartFeb 28, 2023
Primary CompletionMay 16, 2024
Study CompletionMay 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.4 years ago

Interventions

Donanemabdrug

Administered IV

Placebodrug

Administered IV

Dexamethasonedrug

Administered IV