- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388152
Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease
November 27, 2019 updated by: H. Lundbeck A/S
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lu AF20513, low dose (Cohort 1)
10 Patients with mild Alzheimer's.
|
|
Experimental: Lu AF20513, medium dose (Cohort 2)
10 Patients with mild Alzheimer's.
|
|
Experimental: Lu AF20513, high dose (Cohort 3)
15 Patients with mild Alzheimer's.
|
|
Experimental: Lu AF20513, double high dose (Cohort 4)
15 Patients with mild Alzheimer's.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to week 96
|
Antibody titre
Time Frame: Baseline to week 96
|
Baseline to week 96
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
July 4, 2019
Study Completion (Actual)
July 4, 2019
Study Registration Dates
First Submitted
March 3, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Actual)
November 29, 2019
Last Update Submitted That Met QC Criteria
November 27, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16026A
- 2014-001797-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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