I5T-MC-AACI: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507303-55-00

Acronym

I5T-MC-AACI

Enrollment

224

Registered

2024-10-01

Start date

2020-09-30

Completion date

2025-09-17

Last updated

2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).

Interventions

DRUGFLORBETAPIR

DRUGPlacebo to match LY

DRUGFlortaucipir

DRUGDonanemab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population).	—

Countries

Czechia, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026