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

Lundbeck

Status and phase

Terminated

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Lu AF20513

Study type

Interventional

Funder types

Industry

Identifiers

NCT03668405

16026B

2014-001797-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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