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

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

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