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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Lu AF20513; Biological: booster vaccine

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland
    • University of Eastern Finland, Brain Research Unit (FI002)
  • Turku, Finland
    • Clinical Research Services Turku Oy (FI001)
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital, Huddinge (SE001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2018
• Primary Completion (ACTUAL): June 27, 2019
• Study Completion (ACTUAL): June 27, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (ACTUAL): January 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 18086A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No