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| ID | Type | Description | Link |
|---|---|---|---|
| 54861911ALZ0002 | Other Identifier | Janssen Research & Development, LLC | |
| 2018-000403-17 | EudraCT Number | European Medicines Agency (EudraCT) |
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The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.
This is an exploratory Phase 0 study in participants who previously participated in studies (54861911ALZ2002 [NCT02260674], 54861911ALZ2003 [NCT02569398], or 54861911ALZ2004 [NCT02406027]) with atabecestat. In this study, participants will only have blood drawn. The primary hypotheses for this study is that adverse event of elevated liver enzymes observed in some participants is caused by a T-cell dependent inflammatory response. Participants will be monitored for adverse events and will be called 1 day after the blood draw to assess for any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Elevated Liver Enzymes | Experimental | Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat. |
|
| Participants Without Elevated Liver Enzymes | Active Comparator | Blood samples will be collected on Day 1 from participants who completed at least 3 months of dosing with atabecestat and who did not have the elevated liver enzymes (adverse event) while on atabecestat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atabecestat | Drug | Blood samples will be collected from participants previously treated with atabecestat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response | Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response (via cluster of differentiation [CD] 4+ T-cells and CD8+ T-cells) will be determined. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants T-cell Receptor (TCR) Sequencing | Participants TCR sequencing will be performed to determine if any particular TCR repertoire is associated with a risk of developing an elevation in liver enzymes following exposure to atabecestat. Participants T-cell receptor repertoire will be sequenced via TCR sequencing techniques. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Hoge Beuken | Hoboken | 2660 | Belgium | |||
| Hôpital Fernand Widal |
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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 |
|---|---|
| C000634126 | atabecestat |
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|
| Paris |
| 75010 |
| France |
| CTC North GmbH & Co. KG | Hamburg | 20251 | Germany |
| Fundacion Ace | Barcelona | 08014 | Spain |
| Minnesmottagningen, M51 | Stockholm | 141 86 | Sweden |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |