A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)

Phase 1

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Lu AF20513

• Registration Number: NCT03668405
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-26
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Primary Completion: 2019-05-27
• Study Completion: 2019-05-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF20513 high dose	Lu AF20513	-

Primary Outcome Measures

Name	Time	Method
Aβ-specific antibody titre in plasma	Baseline to week 96
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Baseline to week 96	Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans)

Trial Locations

Locations (4)

FI001; 🇫🇮 Turku, Finland

SE003; 🇸🇪 Mölndal, Sweden

SE001; 🇸🇪 Stockholm, Sweden

SE002; 🇸🇪 Malmö, Sweden