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| ID | Type | Description | Link |
|---|---|---|---|
| I9M-MC-ONAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.
Participation in the study will last approximately 9 months with visits about once a month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3439539 | Experimental | LY3439539 administered intravenously (IV) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3439539 | Drug | Administered IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL) | Baseline through end of the Follow-up Period (Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Phospho-Tau (pTau) | Baseline through end of the Follow-up Period (Week 24) | |
| Change from Baseline in Plasma NfL | Baseline through end of the Follow-up Period (Week 24) | |
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Inclusion Criteria:
Exclusion Criteria:
Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
Have a screening MRI that shows evidence of significant abnormality.
Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.
Have a history of
Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions
Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
Have criteria that would preclude a lumbar puncture (LP).
Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Not yet recruiting | Adelaide | 5042 | Australia |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax) |
| Baseline through end of the Follow-up Period (Week 24) |
| PK: Minimum LY3439539 Serum Concentration (Cmin) | Time Frame: Baseline through end of Follow up Period (Week 24) |
| University of the Sunshine Coast Clinical Trial Centre | Not yet recruiting | Birtinya | 4575 | Australia |
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| Austin Health - Heidelberg Repatriation Hospital | Recruiting | Ivanhoe | 3079 | Australia |
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| Southern Neurology | Recruiting | Kogarah | 2217 | Australia |
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| Macquarie University Hospital | Recruiting | Macquarie University | 2109 | Australia |
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| The Alfred | Recruiting | Melbourne | 3004 | Australia |
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| Lilly Centre for Clinical Pharmacology | Recruiting | Singapore | 138623 | Singapore |
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| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |