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Atabecestat

Phase 1

Alzheimer Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Atabecestat · 1 trial · 1 indication

Early Phase 1 1
NCT03587376Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)Alzheimer Disease
COMPLETED9 Analytics
EARLY_PHASE1COMPLETED
Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response
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 Endpoints

Participants T-cell Receptor (TCR) Sequencing
Day 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Participants with Elevated Liver EnzymesEXPERIMENTALBlood samples will be collected on Day 1 from participants previously treated with atabecestat and who had elevated liver enzymes while on atabecestat.
Participants Without Elevated Liver EnzymesACTIVE_COMPARATORBlood 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.

Interventions

NameTypeDescription
AtabecestatDRUGBlood samples will be collected from participants previously treated with atabecestat.
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 s...

Countries:BelgiumFranceGermanySpainSweden
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Frequently asked questions about Atabecestat

What is Atabecestat used for?

Atabecestat is an investigational small molecule being studied for the treatment of Alzheimer Disease. It is being developed by Johnson & Johnson (JNJ). The drug is in early clinical development, with a completed Phase 1 trial that characterized T-cell responses in participants previously treated with the drug.

Who makes Atabecestat?

Atabecestat is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule intended for the treatment of Alzheimer Disease and is currently in early-stage clinical development.

What phase is Atabecestat in?

Atabecestat is in Phase 1 clinical development. A completed early Phase 1 trial, NCT03587376, evaluated the drug in participants with Alzheimer Disease. The drug is investigational and has not been approved by regulatory authorities, as it remains in clinical development.

What clinical trials is Atabecestat in?

Atabecestat has one completed clinical trial, NCT03587376, titled "Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)." This early Phase 1 study enrolled 9 participants with Alzheimer Disease across Belgium, France, Germany, Spain, and Sweden.

Is Atabecestat the same as JNJ-54861911?

Yes, Atabecestat is also known as JNJ-54861911. The clinical trial NCT03587376 explicitly refers to the drug as JNJ-54861911 (Atabecestat), confirming that these names refer to the same investigational compound being developed for Alzheimer Disease.