COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02388152
Recruitment Status : Terminated (New data: The study was terminated based on new efficacy data from another study)
First Posted : March 13, 2015
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE March 3, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date November 29, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date July 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • 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
  • Antibody titre [ Time Frame: Baseline to week 96 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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 48 ]
    ECGs, physical examinations (including neurological), suicidality assessment, Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans
  • Antibody titre [ Time Frame: Baseline to week 48 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease
Official Title  ICMJE Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Lu AF20513, low dose
  • Drug: Lu AF20513, medium dose
  • Drug: Lu AF20513, high dose
  • Drug: Lu AF20513, double high dose
Study Arms  ICMJE
  • Experimental: Lu AF20513, low dose (Cohort 1)
    10 Patients with mild Alzheimer's.
    Intervention: Drug: Lu AF20513, low dose
  • Experimental: Lu AF20513, medium dose (Cohort 2)
    10 Patients with mild Alzheimer's.
    Intervention: Drug: Lu AF20513, medium dose
  • Experimental: Lu AF20513, high dose (Cohort 3)
    15 Patients with mild Alzheimer's.
    Intervention: Drug: Lu AF20513, high dose
  • Experimental: Lu AF20513, double high dose (Cohort 4)
    15 Patients with mild Alzheimer's.
    Intervention: Drug: Lu AF20513, double high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
35
Actual Study Completion Date  ICMJE July 4, 2019
Actual Primary Completion Date July 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Finland,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02388152
Other Study ID Numbers  ICMJE 16026A
2014-001797-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP