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Alzheimer DiseasePhase 1NCT02388152

Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease

A Phase 1 study testing Lu AF20513, low dose, Lu AF20513, medium dose and Lu AF20513, high dose in people with Alzheimer Disease, run by H. Lundbeck A/S at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Lu AF20513, low dose, Lu AF20513, medium dose and Lu AF20513, high dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesin 3 countries
Study dates
Mar 2015to 4 Jul 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 a diagnosis of probable Alzheimer's Disease (AD) consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • The patient has a pattern of antibodies in cerebrospinal fluid (CSF) consistent with an amyloid plaque load
  • The patient is a man or a woman, and between ≥60 and ≤85 years of age
  • The patient has an MRI (performed within 3 months before screening) with results consistent with the diagnosis of probable AD
  • The patient has a mild severity of dementia
  • The patient has a knowledgeable and reliable caregiver who will be available and able to: accompany the patient to all clinical visits, monitor IRE after each immunization, and participate with the patient at all phone visits during the study AD
  • Patients must have completed Part A before being eligible for continued immunisations in Part B

Main Exclusion Criteria:

  • The patient has evidence of mixed etiology of dementia (i.e. absence of other neurodegenerative, neuroinflammatory or cerebrovascular disease, or another neurological, mental or systemic disease or condition likely contributing to cognitive decline)
  • The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia
  • The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-5-TR) Axis I disorder other than AD; including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress disorder and/or cognitive disorder not otherwise specified, (note: patients may be included if treated with a stable dose of antidepressants for at least 2 months and not fulfilling DSM-5-TR criteria for depression at Screening)
  • The patient's eligibility MRI scan (1.5T) shows findings that correspond to more than 4 brain micro haemorrhages
  • The patient has extensive white matter lesions as shown on the screening MRI scan (1.5T)

Other protocol-defined inclusion and exclusion criteria do apply

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Sweden3 sites

  • SE002

    Malmö

  • SE003

    Mölndal

  • SE001

    Stockholm

Other trials in Sweden

Austria1 site

  • AT001

    Vienna

Other trials in Austria

Finland1 site

  • FI001

    Turku

Other trials in Finland

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 determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease.

Being tested
Lu AF20513, low dose, Lu AF20513, medium dose, Lu AF20513, high dose, Lu AF20513, double high dose
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 AF20513, low doseDrug

  • Lu AF20513, medium doseDrug

  • Lu AF20513, high doseDrug

  • Lu AF20513, double high doseDrug

Study groups in NCT02388152
Study groupRoleWhat they receive
Lu AF20513, low dose (Cohort 1)Experimental10 Patients with mild Alzheimer's.
Receives: Drug: Lu AF20513, low dose
Lu AF20513, medium dose (Cohort 2)Experimental10 Patients with mild Alzheimer's.
Receives: Drug: Lu AF20513, medium dose
Lu AF20513, high dose (Cohort 3)Experimental15 Patients with mild Alzheimer's.
Receives: Drug: Lu AF20513, high dose
Lu AF20513, double high dose (Cohort 4)Experimental15 Patients with mild Alzheimer's.
Receives: Drug: Lu AF20513, double high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs

    ECGs, physical and neurological examination, suicidality assessment, Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans

    Measured: Baseline to week 96

  2. Antibody titre

    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.

  1. First posted13 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion4 Jul 2019
  4. Study completion4 Jul 2019

Why it stopped: New data: The study was terminated based on new efficacy data from another study

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388152
Sponsor's protocol ID
16026A
Other IDs
2014-001797-34, 2014
Status last verified
Nov 2019
First submitted
3 Mar 2015
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lu AF20513, low dose, Lu AF20513, medium dose and Lu AF20513, high dose in people with Alzheimer Disease, run by H. Lundbeck A/S at 5 sites in 3 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 29 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 5 sites in Sweden, Austria, 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?

Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs (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?

On the ClinicalTrials.gov record for NCT02388152.

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 29 Nov 2019.

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