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

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ClinicalTrials.gov Identifier: NCT02388152
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: Lu AF20513, low dose Biological: Lu AF20513, medium dose Biological: Lu AF20513, high dose Biological: Lu AF20513, double high dose Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lu AF20513, low dose (Cohort 1)
10 Patients with mild Alzheimer's.
Biological: Lu AF20513, low dose
Experimental: Lu AF20513, medium dose (Cohort 2)
10 Patients with mild Alzheimer's.
Biological: Lu AF20513, medium dose
Experimental: Lu AF20513, high dose (Cohort 3)
15 Patients with mild Alzheimer's.
Biological: Lu AF20513, high dose
Experimental: Lu AF20513, double high dose (Cohort 4)
15 Patients with mild Alzheimer's.
Biological: Lu AF20513, double high dose



Primary Outcome Measures :
  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 [ Time Frame: Baseline to week 96 ]
    ECGs, physical and neurological examination, suicidality assessment, Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans

  2. Antibody titre [ Time Frame: Baseline to week 96 ]


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388152


Locations
Finland
FI001
Turku, Finland
Sweden
SE002
Malmö, Sweden
SE003
Mölndal, Sweden
SE001
Stockholm, Sweden
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02388152     History of Changes
Other Study ID Numbers: 16026A
2014-001797-34 ( EudraCT Number )
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders