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Completed

NCT Number: NCT03587376

Characterization of T-Cell Response in Participants 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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ziekenhuis Hoge Beuken, Hoboken, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Atabecestat

Drug

Blood samples will be collected from participants previously treated with atabecestat.

Other names: JNJ-54861911

Primary outcomes

  1. 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

  1. Participants T-cell Receptor (TCR) Sequencing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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