Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD

Alzheimer Disease Clinical Trial

Official title: Interventional, Open-label, Multiple-immunisation Study of the Immunogenicity, Pharmacodynamics and Safety of Lu AF20513 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment Due to Alzheimer's Disease

Status Terminated

Clinical Trial Summary

The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.

Clinical Trial Description

Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen 1.

Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly assigned to two arms:

• dose regimen 2: 10 patients who will receive one administration of booster vaccine 4 weeks prior to the first IMP administration

• dose regimen 3: 10 patients who will not receive a booster vaccine

After the PA1, the study consists of the following periods:

• Screening Period - up to 12 weeks

• Priming period: 28 weeks, monthly dosing with Lu AF20513

• Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513

• Follow-up Period - 4 weeks ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

• NCT number: NCT03819699
• Study type: Interventional
• Source: H. Lundbeck A/S
• Status: Terminated
• Phase: Phase 1
• Start date: December 12, 2018
• Completion date: June 27, 2019