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

NCT ID: NCT03819699

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2019-06-27

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

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 - dose regimen 1

Cohort 1: encompasses patients enrolled prior to the PA1

Group Type: EXPERIMENTAL

Lu AF20513

Intervention Type: DRUG

Lu AF20513 suspension for injection

Cohort 2 - dose regimen 2

Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration

Group Type: EXPERIMENTAL

Lu AF20513

Intervention Type: DRUG

Lu AF20513 suspension for injection

booster vaccine

Intervention Type: BIOLOGICAL

booster vaccine (Cohort 2) - to be administered as per national recommendations

Cohort 2 - dose regimen 3

Cohort 2: 10 patients who will not receive a booster vaccine

Group Type: EXPERIMENTAL

Lu AF20513

Intervention Type: DRUG

Lu AF20513 suspension for injection

Interventions

Lu AF20513

Lu AF20513 suspension for injection

Intervention Type: DRUG

booster vaccine

booster vaccine (Cohort 2) - to be administered as per national recommendations

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

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

Countries

Finland; Sweden

Other Identifiers

18086A

Identifier Type: -

Identifier Source: org_study_id