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

Early Phase 1CompletedNCT03587376

Janssen Research & Development, LLC9 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

AtabecestatDRUG

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (5)

Ziekenhuis Hoge Beuken

Hoboken, Belgium

Hôpital Fernand Widal

Paris, France

CTC North GmbH & Co. KG

Hamburg, Germany

Fundacion Ace

Barcelona, Spain

Minnesmottagningen, M51

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: Day 1

Data from ClinicalTrials.gov

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