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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001797-34 | EudraCT Number |
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New data: The study was terminated based on new efficacy data from another study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF20513, low dose (Cohort 1) | Experimental | 10 Patients with mild Alzheimer's. |
|
| Lu AF20513, medium dose (Cohort 2) | Experimental | 10 Patients with mild Alzheimer's. |
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| Lu AF20513, high dose (Cohort 3) | Experimental | 15 Patients with mild Alzheimer's. |
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| Lu AF20513, double high dose (Cohort 4) | Experimental | 15 Patients with mild Alzheimer's. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF20513, low dose | Drug |
| ||
| Lu AF20513, medium dose |
| 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 | 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 | Baseline to week 96 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria do apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AT001 | Vienna | Austria | ||||
| FI001 |
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| Drug |
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| Lu AF20513, high dose | Drug |
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| Lu AF20513, double high dose | Drug |
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| Turku |
| Finland |
| SE002 | Malmö | Sweden |
| SE003 | Mölndal | Sweden |
| SE001 | Stockholm | Sweden |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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