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

Alzheimer's Disease Clinical Trial

Official title:

Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03668405
• Other study ID #: 16026B
• Secondary ID: 2014-001797-34
• Status: Terminated
• Phase: Phase 1
• Start date: June 26, 2018
• Est. completion date: May 27, 2019

Study information

• Verified date: November 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Main inclusion criteria:

• The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.

• The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.

• The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study

Main exclusion criteria:

• The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.

• The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability

More inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Lu AF20513
Injection

Locations

Country	Name	City	State
Finland	FI001	Turku
Sweden	SE002	Malmö
Sweden	SE003	Mölndal
Sweden	SE001	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	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)	Baseline to week 96
Primary	Aß-specific antibody titre in plasma		Baseline to week 96