Alzheimer Disease
Conditions
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.
Interventions
DRUGLu AF20513, low dose
DRUGLu AF20513, medium dose
DRUGLu AF20513, high dose
DRUGLu AF20513, double high dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Antibody titre | Baseline to week 96 | — |
Countries
Austria, Finland, Sweden
Outcome results
None listed