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NBI-1117567

Phase 2

Alzheimer's Disease | Small molecule | Other |Neurocrine Biosciences, Inc.|Last Updated: Sep 22, 2026

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

NBI-1117567 · 1 trial · 1 indication

Phase 2 1
NCT07832383Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase InhibitorAlzheimer's Disease
NOT YET_RECRUITING135 Analytics
PHASE2NOT YET_RECRUITING
Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
Baseline, Day 85

Secondary Endpoints

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85
Baseline, Day 85
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85
Baseline, Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NBI-1117567 Low DoseEXPERIMENTALParticipants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks.
NBI-1117567 High DoseEXPERIMENTALParticipants will receive the titration dose of NBI-1117567 followed by the target dose (high dose) for 10 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo for 12 weeks.

Interventions

NameTypeDescription
NBI-1117567DRUGNBI-1117567 will be administered per schedule specified in the arm description.
PlaceboDRUGPlacebo matching to NBI-1117567 will be administered per schedule specified in the arm description.
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Participant has a primary diagnosis of mild to moderate AD prior to screening. * Participant is receiving a well-tolerated treatment with an acetylcholinesterase inhibitor (donepezil, galantamine, or rivastigmine) at a stable dose for at least 3 months prior to the Screeni...

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Recent Changes (Last 90 Days)

LOWSep 22, 2026NCT07832383NEW_TRIAL: changed
LOWSep 22, 2026NCT07832383NEW_TRIAL: changed