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

NCT03819699 | Terminated Phase 1

• 1 other identifier: 18086A
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Amyloid load

  From baseline to week 84

Study Arms (3)

Cohort 1 - dose regimen 1

EXPERIMENTAL

Cohort 1: encompasses patients enrolled prior to the PA1

Drug: Lu AF20513

Cohort 2 - dose regimen 2

EXPERIMENTAL

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

Drug: Lu AF20513; Biological: booster vaccine

Cohort 2 - dose regimen 3

EXPERIMENTAL

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

Drug: Lu AF20513

Interventions

Lu AF20513 DRUG

Lu AF20513 suspension for injection

Cohort 1 - dose regimen 1; Cohort 2 - dose regimen 2; Cohort 2 - dose regimen 3

booster vaccine BIOLOGICAL

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

Cohort 2 - dose regimen 2

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (3)

University of Eastern Finland, Brain Research Unit (FI002)

Kuopio, Finland

Location

Clinical Research Services Turku Oy (FI001)

Turku, Finland

Location

Karolinska University Hospital, Huddinge (SE001)

Stockholm, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 28, 2019
• Study Start: December 12, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

SE (1); FI (2)