Not yet recruitingPhase 2

Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor

A Phase 2a, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease on Stable Treatment With an Acetylcholinesterase Inhibitor

Lead sponsor

Neurocrine Biosciences

Asset

NBI-1117567

Listed sites

Recruiting sites

Enrollment

135

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Neuropsychological Test Battery (NTB) Composite Score

Identifiers

Registered as

Org study IDNBI-1117567-ADC2038

NCT IDNCT07832383

Timeline

Milestones

Study first posted2026-09-22actual

Last update posted2026-09-22actual

Study start2026-10estimated (month precision)

Primary completion2028-05estimated (month precision)

Study completion2028-06estimated (month precision)

Assets

Drug assets

NBI-1117567

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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 Screening Visit and is required to continue the same treatment at the same dose level throughout the study.

•Negative pregnancy test at screening and Day 1 for participants of childbearing potential.

•Participant is willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Participant can follow instructions and understand and perform all study procedures, including cognitive assessments in the opinion of the investigator

Exclusion criteria

•Pregnant (that is, positive pregnancy test at screening, or baseline [Day 1]) or lactating, or plans to become pregnant during the study.

•Participant has other medical or neurological condition or prior clinical findings indicative of alternate or additional causes of cognitive impairment, including but not limited to vascular dementia, multi-infarct dementia, normal pressure hydrocephalus, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, multiple sclerosis, amyotrophic lateral sclerosis, hypoxic cerebral damage, encephalitis, central nervous system (CNS) infection, chronic traumatic encephalopathy, and history of head injury with loss of consciousness.

•Participant has an unstable medical condition within the 3 months prior to screening or clinically relevant medical condition interfering with the study as judged by the investigator, as determined from the medical history review and the physical examinations obtained during screening.

•Participant has any primary psychiatric condition or severe psychiatric symptom that in the opinion of the investigator may interfere with the participant's ability to participate in the study or impact the interpretation of study results.

•Participant is undergoing psychological therapy interventions for cognition in AD. Participants undergoing cognitive behavioral therapy for conditions other than AD must be stable for 3 months prior to Day 1 and during the study.

•Participant has previously participated in an interventional clinical study within the preceding 180 days, or 5 half-lives of the experimental treatment, whichever is longer.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, Day 85

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85

Time frame:Baseline, Day 85

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85

Time frame:Baseline, Day 85

ADAS-Cog

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.