drugset / Trial / NCT03639987

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

NCT03639987

Phase 2 Terminated 52 enrolled Biogen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.

Timeline

Start
2018-12-20
Primary completion
2019-07-30
Completion
2019-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Aducanumab Monoclonal antibody Intravenous

Indications