I5T-MC-AACO: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522340-40-00

Acronym

I5T-MC-AACO

Enrollment

170

Registered

2025-10-30

Start date

2025-12-04

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

Brief summary

Change from Baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology populations. [Time Frame: Baseline, Week 76]

Interventions

DRUGFLORBETAPIR

DRUGDonanemab

DRUGFlortaucipir

DRUGSODIUM CHLORIDE PH. EUR.

DRUGFlortaucipir F18

DRUGFlorbetapir F18

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology populations. [Time Frame: Baseline, Week 76]	—

Countries

Poland, Spain

Outcome results

None listed

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