NCT03819699

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Lu AF20513	Lu AF20513 suspension for injection
BIOLOGICAL	booster vaccine	booster vaccine (Cohort 2) - to be administered as per national recommendations

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2019-01-28
• Last updated: 2020-02-21

Locations

3 sites across 2 countries: Finland, Sweden