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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Lu AF20513 suspension for injection
booster vaccine (Cohort 2) - to be administered as per national recommendations
University of Eastern Finland, Brain Research Unit (FI002)
Kuopio, Finland
Clinical Research Services Turku Oy (FI001)
Turku, Finland
Karolinska University Hospital, Huddinge (SE001)
Stockholm, Sweden
AUC
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Time frame: From Week 0 to Week 28
Cmax
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Time frame: 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
Time frame: From Week 0 to Week 28
Amyloid load
Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)
Time frame: From baseline to week 84
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