Clincosm LogoSign in Get a demo

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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT02388152
Collaborator
(none)
50
Enrollment
5
Locations
4
Arms
52.1
Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Lu AF20513, low dose
  • Drug: Lu AF20513, medium dose
  • Drug: Lu AF20513, high dose
  • Drug: Lu AF20513, double high dose
 Phase 1

Study Design

Study Type:
Interventional
Actual 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 :
Mar 1, 2015
Actual Primary Completion Date :
Jul 4, 2019
Actual Study Completion Date :
Jul 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lu AF20513, low dose (Cohort 1)

10 Patients with mild Alzheimer's.

Drug: Lu AF20513, low dose
Experimental: Lu AF20513, medium dose (Cohort 2)

10 Patients with mild Alzheimer's.

Drug: Lu AF20513, medium dose
Experimental: Lu AF20513, high dose (Cohort 3)

15 Patients with mild Alzheimer's.

Drug: Lu AF20513, high dose
Experimental: Lu AF20513, double high dose (Cohort 4)

15 Patients with mild Alzheimer's.

Drug: Lu AF20513, double high dose

Outcome Measures

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 [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 [Baseline to week 96]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AT001 Wien Austria
2 FI001 Turku Finland
3 SE002 Malmö Sweden
4 SE003 Mölndal Sweden
5 SE001 Stockholm Sweden

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT02388152
Other Study ID Numbers:
  • 16026A
  • 2014-001797-34
First Posted:
Mar 13, 2015
Last Update Posted:
Nov 29, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Nov 29, 2019