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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587376
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Atabecestat Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : August 23, 2018

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Arms and Interventions
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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 Name: 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 Name: JNJ-54861911


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587376


Locations
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Belgium
Ziekenhuis Hoge Beuken
Hoboken, Belgium, 2660
France
Hôpital Fernand Widal
Paris, France, 75010
Germany
CTC North GmbH & Co. KGim Spectrum am UKE
Hamburg, Germany, 20251
Spain
Fundacion Ace
Barcelona, Spain, 08014
Sweden
Minnesmottagningen, M51
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03587376    
Other Study ID Numbers: CR108462
54861911ALZ0002 ( Other Identifier: Janssen Research & Development, LLC )
2018-000403-17 ( EudraCT Number: European Medicines Agency (EudraCT) )
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders