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

NCT03587376 | Completed Early Phase 1

• 3 other identifiers: CR10846254861911ALZ00022018-000403-17
• Study Type: interventional
• Target: 9
• Locations: 5 countries
• Sites: 5

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participants T-cell Receptor (TCR) Sequencing

  Day 1

Study Arms (2)

Participants with Elevated Liver Enzymes

EXPERIMENTAL

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

Participants Without Elevated Liver Enzymes

ACTIVE COMPARATOR

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

Interventions

Atabecestat DRUG

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

Also known as: JNJ-54861911

Participants Without Elevated Liver Enzymes; Participants with Elevated Liver Enzymes

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Ziekenhuis Hoge Beuken

Hoboken, 2660, Belgium

Location

Hôpital Fernand Widal

Paris, 75010, France

Location

CTC North GmbH & Co. KG

Hamburg, 20251, Germany

Location

Fundacion Ace

Barcelona, 08014, Spain

Location

Minnesmottagningen, M51

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

atabecestat

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 16, 2018
• Study Start: May 30, 2018
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

DE (1); BE (1); SE (1); FR (1); ES (1)