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| ID | Type | Description | Link |
|---|---|---|---|
| H8A-MC-LZAT | Other Identifier | Eli Lilly and Company |
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The purpose of this trial is to compare the average change in the amount of amyloid beta species in blood after an infusion of solanezumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Older adults with mild Dementia Alzheimer's Type (DAT) |
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| Group 2 | Experimental | Older adult controls with possible Alzheimer's Disease Pathology |
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| Group 3 | Experimental | Older adult controls with no evidence of Alzheimer's Disease |
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| Group 4 | Experimental | Younger subjects who are assumed to have no cognitive impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solanezumab | Drug | 400mg administered once intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline up to 112 days post drug administration in plasma levels of Aβ fragment-2 in (Group 1) and (Group 3) | Baseline up to 112 days post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in plasma levels of Aβ1-42 after solanezumab infusion | Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose | |
| Mean change in plasma levels of Aβ1-40 species after solanezumab infusion | Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose |
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Inclusion Criteria:
Individuals in Groups 1, 2, and 3, described below, will be participants in the longitudinal studies of memory and aging at the Washington University Alzheimer's Disease Research Center (WU-ADRC). These participants must have results from apolipoprotein E (ApoE) genotyping from the WU-ADRC. At the beginning of the study they must be between 45 and 90 years of age and if a female of childbearing potential, not be breastfeeding, test negative for pregnancy, and be using a medically accepted form of birth control at the time of the infusion and for 6 months afterward. Subjects must also meet the criteria below for each study group
Group 1, Mild dementia of Alzheimer's type (DAT):
Group 2, Older Adult Controls with Possible AD Pathology:
Have no cognitive impairment as indicated by a CDR rating of 0. Have possible AD pathology, as determined by florbetapir PET imaging.
Group 3, Older Adult Controls with No Evidence of AD Pathology:
Have no cognitive impairment as indicated by a CDR rating of 0. Have no evidence of AD pathology as determined by florbetapir PET imaging.
Individuals recruited into Group 4 will not be participants in the longitudinal studies of memory and aging at WU-ADRC. To be included in Group 4, individuals must meet these criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St Louis | Missouri | 63108 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C550616 | solanezumab |
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| Mean change in plasma levels of modified Aβ species after solanezumab infusion | Baseline (pre-dose); 30 minutes; 24 hours; 7, 28, 56 and 112 days post-dose |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |