Alzheimer Disease
Conditions
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.
Interventions
DRUGAtabecestat
Blood samples will be collected from participants previously treated with atabecestat.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response | 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
| Measure | Time frame | Description |
|---|---|---|
| Participants T-cell Receptor (TCR) Sequencing | Day 1 | 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. |
Countries
Belgium, France, Germany, Spain, Sweden
Outcome results
None listed