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

Phase 1

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: Lu AF20513; Biological: booster vaccine

• Registration Number: NCT03819699
• Lead Sponsor: H. Lundbeck A/S

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

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - dose regimen 2	booster vaccine	Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
Cohort 2 - dose regimen 3	Lu AF20513	Cohort 2: 10 patients who will not receive a booster vaccine
Cohort 1 - dose regimen 1	Lu AF20513	Cohort 1: encompasses patients enrolled prior to the PA1
Cohort 2 - dose regimen 2	Lu AF20513	Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

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