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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Atabecestat
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ziekenhuis Hoge Beuken
  • Hôpital Fernand Widal
  • CTC North GmbH & Co. KGim Spectrum am UKE
  • Fundacion Ace
  • Minnesmottagningen, M51

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participants with Elevated Liver Enzymes

Participants Without Elevated Liver Enzymes

Arm Description

Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2018
Last Updated
October 3, 2019
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03587376
Brief Title
Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)
Official Title
Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Elevated Liver Enzymes
Arm Type
Experimental
Arm Description
Blood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat.
Arm Title
Participants Without Elevated Liver Enzymes
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atabecestat
Other Intervention Name(s)
JNJ-54861911
Intervention Description
Blood samples will be collected from participants previously treated with atabecestat.
Primary Outcome Measure Information:
Title
Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response
Description
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 Outcome Measure Information:
Title
Participants T-cell Receptor (TCR) Sequencing
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Ziekenhuis Hoge Beuken
City
Hoboken
ZIP/Postal Code
2660
Country
Belgium
Facility Name
Hôpital Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CTC North GmbH & Co. KGim Spectrum am UKE
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Fundacion Ace
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Facility Name
Minnesmottagningen, M51
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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