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

• Status: Terminated
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

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