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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Lu AF20513
* Biological: booster vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - dose regimen 1<br>Cohort 1: encompasses patients enrolled prior to the PA1 | Drug: Lu AF20513<br>* Lu AF20513 suspension for injection<br>|
| Experimental: Cohort 2 - dose regimen 2<br>Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration | Drug: Lu AF20513<br>* Lu AF20513 suspension for injection<br>Biological: booster vaccine<br>* booster vaccine (Cohort 2) - to be administered as per national recommendations<br>|
| Experimental: Cohort 2 - dose regimen 3<br>Cohort 2: 10 patients who will not receive a booster vaccine | Drug: Lu AF20513<br>* Lu AF20513 suspension for injection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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