Back to resultsA Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lu AF20513
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Main inclusion criteria:
- The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.
- The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.
- The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study
Main exclusion criteria:
- The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.
- The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability
More inclusion and exclusion criteria may apply
Sites / Locations
- FI001
- SE002
- SE003
- SE001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lu AF20513 high dose
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans)
Aβ-specific antibody titre in plasma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03668405
Brief Title
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Official Title
Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
New data: The study was terminated based on new efficacy data from another study
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
May 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lu AF20513 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lu AF20513
Intervention Description
Injection
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans)
Time Frame
Baseline to week 96
Title
Aβ-specific antibody titre in plasma
Time Frame
Baseline to week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria:
The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.
The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.
The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study
Main exclusion criteria:
The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.
The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability
More inclusion 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
FI001
City
Turku
Country
Finland
Facility Name
SE002
City
Malmö
Country
Sweden
Facility Name
SE003
City
Mölndal
Country
Sweden
Facility Name
SE001
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
We'll reach out to this number within 24 hrs