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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-05-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lu AF20513 high dose

Group Type EXPERIMENTAL

Lu AF20513

Intervention Type DRUG

Injection

Interventions

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Lu AF20513

Injection

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No