NCT03587376

Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)

Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Atabecestat	Blood samples will be collected from participants previously treated with atabecestat.

Timeline

• Start date: 2018-05-30
• Primary completion: 2018-08-23
• Completion: 2018-08-23
• First posted: 2018-07-16
• Last updated: 2025-04-27

Locations

5 sites across 5 countries: Belgium, France, Germany, Spain, Sweden