Study Stopped
New data: The study was terminated based on new efficacy data from another study
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
2 other identifiers
interventional
18
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2018
CompletedFirst Submitted
Initial submission to the registry
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2019
CompletedNovember 21, 2019
November 1, 2019
11 months
September 11, 2018
November 20, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Baseline to week 96
Aβ-specific antibody titre in plasma
Baseline to week 96
Study Arms (1)
Lu AF20513 high dose
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (4)
FI001
Turku, Finland
SE002
Malmo, Sweden
SE003
Mölndal, Sweden
SE001
Stockholm, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 12, 2018
Study Start
June 26, 2018
Primary Completion
May 27, 2019
Study Completion
May 27, 2019
Last Updated
November 21, 2019
Record last verified: 2019-11