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)

The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Hoboken, Belgium, 2660
    • Ziekenhuis Hoge Beuken
• France
  • Paris, France, 75010
    • Hôpital Fernand Widal
• Germany
  • Hamburg, Germany, 20251
    • CTC North GmbH & Co. KG
• Spain
  • Barcelona, Spain, 08014
    • Fundación ACE
• Sweden
  • Stockholm, Sweden, 141 86
    • Minnesmottagningen, M51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Atabecestat; Blood samples will be collected from participants previously treated with atabecestat.; Other Names: JNJ-54861911
Active Comparator: 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.	Drug: Atabecestat; Blood samples will be collected from participants previously treated with atabecestat.; Other Names: JNJ-54861911

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): August 23, 2018
• Study Completion (Actual): August 23, 2018

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: CR108462; 54861911ALZ0002 (Other Identifier: Janssen Research & Development, LLC); 2018-000403-17 (EudraCT Number: European Medicines Agency (EudraCT))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No