Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 9
- Locations
- 5
- Primary Endpoint
- Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response
Study Overview
Brief Summary
The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant who received and discontinued atabecestat in one of the following prior trials (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)
- •Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Willing and able to adhere to the prohibitions and restrictions specified for this study
Exclusion Criteria
- •Anemic based on the last blood draw in the prior atabecestat trial
- •Donated more than (>) 450 milliliter (mL) of blood in the past 3 months
- •Currently participating in an atabecestat study (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)
Arms & Interventions
Participants with Elevated Liver Enzymes
Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat.
Intervention: Atabecestat (Drug)
Participants Without Elevated Liver Enzymes
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.
Intervention: Atabecestat (Drug)
Outcomes
Primary Outcomes
Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response
Time Frame: Day 1
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.
Secondary Outcomes
- Participants T-cell Receptor (TCR) Sequencing(Day 1)