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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2018-08-23

Brief Summary

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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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Detailed Description

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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

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Atabecestat

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Atabecestat

Intervention Type DRUG

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

Interventions

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Atabecestat

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

Intervention Type DRUG

Other Intervention Names

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JNJ-54861911

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No