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TerminatedPhase 1

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD

Interventional, Open-label, Multiple-immunisation Study of the Immunogenicity, Pharmacodynamics and Safety of Lu AF20513 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment Due to Alzheimer's Disease

Lead sponsor

H. Lundbeck A/S

Asset

Lu AF20513

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (CSF)•Tau biomarker required (CSF)

Primary endpoints

•AUC•Cmax•Titre response

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 ID18086A

NCT IDNCT03819699

Timeline

Milestones

Study start2018-12-12actual

Study first posted2019-01-28actual

Primary completion2019-06-27actual

Study completion2019-06-27actual

Last update posted2020-02-21actual

Assets

Drug assets

Lu AF20513

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•The patient has a diagnosis of AD or Mild Cognitive Impairment (MCI) due to AD.

•The patient has evidence of an abnormal amyloid and tau status, consistent with AD, by means of a positive CSF test at screening

•The patient is aged ≥50 and ≤85 years. If a woman, the patient must be post-menopausal

Exclusion criteria

•The patient has participated in a clinical study where he/she has received passive or active anti-Aβ immunotherapy or other active immunisation for the treatment of AD.

•The patient has, in the investigator's opinion, evidence and/or history (clinically or on MRI) of any clinically significant neurodegenerative disease, serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a definite or probable diagnosis of Major or Mild Neuro-Cognitive disorder other than AD, per DSM-5® criteria.

Other in- and exclusion criteria may apply

Endpoints (4)

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

Safety / tolerability / PK

Amyloid biomarkers

Other (unclassified)

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Amyloid load

Time frame:From baseline to week 84

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

AUC

Time frame:From Week 0 to Week 28

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:From Week 0 to Week 28

concentration, descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Titre response

Time frame:From Week 0 to Week 28

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.