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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03819699

Enrollment

Registered

2019-01-28

Start date

2018-12-12

Completion date

2019-06-27

Last updated

2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.

Detailed description

Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen 1. Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly assigned to two arms: * dose regimen 2: 10 patients who will receive one administration of booster vaccine 4 weeks prior to the first IMP administration * dose regimen 3: 10 patients who will not receive a booster vaccine After the PA1, the study consists of the following periods: * Screening Period - up to 12 weeks * Priming period: 28 weeks, monthly dosing with Lu AF20513 * Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513 * Follow-up Period - 4 weeks

Interventions

DRUGLu AF20513

Lu AF20513 suspension for injection

BIOLOGICALbooster vaccine

booster vaccine (Cohort 2) - to be administered as per national recommendations

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
AUC	From Week 0 to Week 28	Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Cmax	From Week 0 to Week 28	maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Titre response	From Week 0 to Week 28	Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment

Secondary

Measure	Time frame	Description
Amyloid load	From baseline to week 84	Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)

Countries

Finland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026