Alzheimer DiseasePhase 1NCT03819699
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
A Phase 1 study testing Lu AF20513 and booster vaccine in people with Alzheimer Disease, run by H. Lundbeck A/S at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lu AF20513 and booster vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Dec 2018to 27 Jun 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
University of Eastern Finland, Brain Research Unit (FI002)
Kuopio
Clinical Research Services Turku Oy (FI001)
Turku
About this study
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
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.
Read the 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
- Conditions
- Alzheimer Disease
- Being tested
- Lu AF20513, booster vaccine
- 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
Lu AF20513 suspension for injection
booster vaccineBiological
booster vaccine (Cohort 2) - to be administered as per national recommendations
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - dose regimen 1 | Experimental | Cohort 1: encompasses patients enrolled prior to the PA1 Receives: 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 Receives: Drug: Lu AF20513; Biological: booster vaccine |
| Cohort 2 - dose regimen 3 | Experimental | Cohort 2: 10 patients who will not receive a booster vaccine Receives: Drug: Lu AF20513 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Measured: From Week 0 to Week 28
Cmax
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Measured: 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
Measured: From Week 0 to Week 28
Secondary outcomes (1)
Amyloid load
Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)
Measured: From baseline to week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start12 Dec 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 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 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT03819699
- Sponsor's protocol ID
- 18086A
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03819699
- Acronym / sponsor ID
- 18086A
- Conditions
- Alzheimer 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
- 3 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 28 Jan 2019 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - dose regimen 1 | Experimental | Drug: Lu AF20513Cohort 1: encompasses patients enrolled prior to the PA1 |
| Cohort 2 - dose regimen 2 | Experimental | Drug: Lu AF20513, Biological: booster vaccineCohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration |
| Cohort 2 - dose regimen 3 | Experimental | Drug: Lu AF20513Cohort 2: 10 patients who will not receive a booster vaccine |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 AF20513Lu AF20513 suspension for injection | Drug | Cohort 1 - dose regimen 1, Cohort 2 - dose regimen 2, Cohort 2 - dose regimen 3 |
| booster vaccinebooster vaccine (Cohort 2) - to be administered as per national recommendations | Biological | Cohort 2 - dose regimen 2 |
Primary outcome
AUC
Time frame: From Week 0 to Week 28
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Cmax
Time frame: From Week 0 to Week 28
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Titre response
Time frame: From Week 0 to Week 28
Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment
1 secondary outcome
Amyloid load
Time frame: From baseline to week 84
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 Feb 2020.
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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
3 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 and booster vaccine in people with Alzheimer Disease, run by H. Lundbeck A/S at 3 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Sweden. 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?
AUC (time frame: From Week 0 to Week 28). The study lists 3 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 Feb 2020.