Back to resultsStudy With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lu AF20513
booster vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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.
Other in- and exclusion criteria may apply
Sites / Locations
- University of Eastern Finland, Brain Research Unit (FI002)
- Clinical Research Services Turku Oy (FI001)
- Karolinska University Hospital, Huddinge (SE001)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1 - dose regimen 1
Cohort 2 - dose regimen 2
Cohort 2 - dose regimen 3
Arm Description
Cohort 1: encompasses patients enrolled prior to the PA1
Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
Cohort 2: 10 patients who will not receive a booster vaccine
Outcomes
Primary Outcome Measures
AUC
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Cmax
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Titre response
Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment
Secondary Outcome Measures
Amyloid load
Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03819699
Brief Title
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
New data: The study was terminated based on new efficacy data from another study
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - dose regimen 1
Arm Type
Experimental
Arm Description
Cohort 1: encompasses patients enrolled prior to the PA1
Arm Title
Cohort 2 - dose regimen 2
Arm Type
Experimental
Arm Description
Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
Arm Title
Cohort 2 - dose regimen 3
Arm Type
Experimental
Arm Description
Cohort 2: 10 patients who will not receive a booster vaccine
Intervention Type
Drug
Intervention Name(s)
Lu AF20513
Intervention Description
Lu AF20513 suspension for injection
Intervention Type
Biological
Intervention Name(s)
booster vaccine
Intervention Description
booster vaccine (Cohort 2) - to be administered as per national recommendations
Primary Outcome Measure Information:
Title
AUC
Description
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Time Frame
From Week 0 to Week 28
Title
Cmax
Description
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Time Frame
From Week 0 to Week 28
Title
Titre response
Description
Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment
Time Frame
From Week 0 to Week 28
Secondary Outcome Measure Information:
Title
Amyloid load
Description
Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)
Time Frame
From baseline to week 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Other in- and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
University of Eastern Finland, Brain Research Unit (FI002)
City
Kuopio
Country
Finland
Facility Name
Clinical Research Services Turku Oy (FI001)
City
Turku
Country
Finland
Facility Name
Karolinska University Hospital, Huddinge (SE001)
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
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Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
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