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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Atabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03587376

CR108462

2018-000403-17 (EudraCT Number)

54861911ALZ0002 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Participants with Elevated Liver Enzymes

Experimental group

Description:

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

Treatment:

Drug: Atabecestat

Participants Without Elevated Liver Enzymes

Active Comparator group

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.

Treatment:

Drug: Atabecestat