Alzheimer's DiseasePhase 1NCT03668405
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
A Phase 1 study testing Lu AF20513 in people with Alzheimer's Disease, run by H. Lundbeck A/S at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Lu AF20513
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Jun 2018to 27 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
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
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Lu AF20513
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF20513Drug
Injection
| Study group | Role | What they receive |
|---|---|---|
| Lu AF20513 high dose | Experimental | Not described Receives: Drug: Lu AF20513 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to week 96
Aβ-specific antibody titre in plasma
Measured: Baseline to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start26 Jun 2018
- Primary completion27 May 2019
- Study completion27 May 2019
Why it stopped: New data: The study was terminated based on new efficacy data from another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668405
- Sponsor's protocol ID
- 16026B
- Other IDs
- 2014-001797-34, 2014
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03668405
- Acronym / sponsor ID
- 16026B
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New data: The study was terminated based on new efficacy data from another study
- Enrolment
- 18 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF20513 high dose | Experimental | Drug: Lu AF20513 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF20513Injection | Drug | Lu AF20513 high dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Baseline to week 96
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
Time frame: Baseline to week 96
Results and safety
The study was stopped early (reason given: New data: The study was terminated based on new efficacy data from another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF20513 in people with Alzheimer's Disease, run by H. Lundbeck A/S at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: New data: The study was terminated based on new efficacy data from another study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Baseline to week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.