TerminatedPhase 1

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

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

Lead sponsor

H. Lundbeck A/S

Asset

Lu AF20513

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Treatment-Emergent Adverse Events•Aβ-specific antibody titre in plasma

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID16026B

NCT IDNCT03668405

Timeline

Milestones

Study start2018-06-26actual

Study first posted2018-09-12actual

Primary completion2019-05-27actual

Study completion2019-05-27actual

Last update posted2019-11-21actual

Assets

Drug assets

Lu AF20513

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Other (unclassified)

Neuroimaging

1 endpoint

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time frame:Baseline to week 96

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Aβ-specific antibody titre in plasma

Time frame:Baseline to week 96

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.