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

Early Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Atabecestat

• Registration Number: NCT03587376
• Lead Sponsor: Janssen Research & Development, LLC

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 Timeline

• Study Start: 2018-05-30
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-16
• Primary Completion: 2018-08-23
• Study Completion: 2018-08-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with Elevated Liver Enzymes	Atabecestat	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	Atabecestat	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Ziekenhuis Hoge Beuken; 🇧🇪 Hoboken, Belgium

Hôpital Fernand Widal; 🇫🇷 Paris, France

Fundacion Ace; 🇪🇸 Barcelona, Spain

CTC North GmbH & Co. KGim Spectrum am UKE; 🇩🇪 Hamburg, Germany

Minnesmottagningen, M51; 🇸🇪 Stockholm, Sweden