The clinical trial will evaluate an investigational oral muscarinic agonist for cognitive impairment in adults with mild to moderate Alzheimer’s disease.
Date: October 20, 2026
Company: Neurocrine Biosciences, Inc.
Drug Candidate: NBI-1117567 (NBI-'567)
Therapeutic Area: Neurology / Alzheimer’s Disease
Clinical Trial Phase: Phase 2
Key Highlights
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Phase 2 Study Initiated: Neurocrine Biosciences has initiated a Phase 2 clinical study evaluating NBI-1117567 in adults with mild to moderate Alzheimer’s disease.
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Investigational Oral Therapy: NBI-1117567 is an M1/M4 (M1-preferring) selective muscarinic agonist designed to activate receptors involved in learning, memory and cognitive function.
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Study Population: The randomized, double-blind, placebo-controlled study is expected to enroll approximately 135 adults aged 50–85 who are receiving stable treatment with an acetylcholinesterase inhibitor.
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Treatment Duration: Participants will receive once-daily NBI-1117567 at a high or low dose, or placebo, during the 12-week study.
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Primary Endpoint: The trial will assess the change from baseline in the Neuropsychological Test Battery (NTB) composite score at Week 12.
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Secondary Endpoints: Additional assessments include changes in the ADAS-Cog13 score and Clinical Dementia Rating (CDR) Sum of Boxes score.
How Does NBI-1117567 Work?
NBI-1117567 is designed to selectively activate M1 and M4 muscarinic receptors, which play roles in neuronal signalling associated with learning and memory. The investigational therapy is being evaluated as an add-on treatment for cognitive impairment in patients already receiving standard acetylcholinesterase inhibitor therapy.
Its potential benefit will be determined through clinical evaluation of cognitive performance, safety, tolerability and pharmacokinetics.
About the Clinical Trial
The Phase 2 study will compare two dose levels of NBI-1117567 with placebo in adults with mild to moderate Alzheimer’s disease. Researchers will evaluate whether the investigational treatment can improve cognitive performance over the treatment period.
Clinical trial identifier: NBI-1117567-ADC2038
ClinicalTrials.gov identifier: NCT07832383
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurodegenerative disorder and the most common cause of dementia. It affects memory, thinking and other cognitive abilities, often reducing a person’s ability to perform everyday activities.
Disruption of cholinergic signalling, which contributes to learning and memory, is one of the neurological changes associated with the disease. Treatments targeting these pathways are being investigated as potential approaches to addressing cognitive symptoms.
Neurocrine Biosciences’ Muscarinic Research Portfolio
Beyond NBI-1117567, Neurocrine Biosciences is advancing a portfolio of investigational medicines targeting muscarinic receptors for neurological and psychiatric conditions, including schizophrenia, bipolar mania and Alzheimer’s disease-related psychosis.
The initiation of this Phase 2 study expands the company’s clinical development efforts in Alzheimer’s disease cognition, an area with substantial unmet medical needs.
What’s Next?
The Phase 2 study will evaluate the efficacy, safety and tolerability of NBI-1117567. Further clinical data will be needed to determine whether the investigational treatment can provide meaningful cognitive benefits for people living with Alzheimer’s disease.
Source: Neurocrine Biosciences, Inc. — October 20, 2026.
