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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587376
• Other study ID #: CR108462
• Secondary ID: 54861911ALZ00022
• Status: Completed
• Phase: Early Phase 1
• Start date: May 30, 2018
• Est. completion date: August 23, 2018

Study information

• Verified date: October 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Atabecestat
Blood samples will be collected from participants previously treated with atabecestat.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Hoge Beuken	Hoboken
France	Hôpital Fernand Widal	Paris
Germany	CTC North GmbH & Co. KGim Spectrum am UKE	Hamburg
Spain	Fundacion Ace	Barcelona
Sweden	Minnesmottagningen, M51	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1