San Diego, California, U.S., October 20, 2026
Neurocrine Biosciences has initiated a Phase 2 clinical study evaluating its investigational drug NBI-1117567 (NBI-567) in adults with mild to moderate Alzheimer’s disease. The oral treatment is being developed as an add-on therapy to address cognitive impairment, including difficulties with memory, attention and thinking. The study will investigate whether selectively activating muscarinic receptors involved in learning and memory can improve cognitive performance in people already receiving stable treatment with an acetylcholinesterase inhibitor. The clinical program represents a further step in Neurocrine Biosciences’ efforts to develop new treatments for neurological conditions with significant unmet medical needs. NBI-567 remains investigational, and its efficacy and safety have not yet been established.
NBI-567 Targets Muscarinic Receptors Involved in Memory
NBI-567 is an orally administered, M1/M4-preferring selective muscarinic agonist designed to activate M1 and M4 receptors involved in neuronal signaling pathways associated with learning, memory and cognition. These receptors are part of the cholinergic system, which plays an important role in normal brain function and is affected in Alzheimer’s disease. The investigational compound is intended to stimulate these receptors while limiting activity at other muscarinic receptor subtypes. According to Neurocrine Biosciences, this selective mechanism may help reduce unwanted effects associated with activity outside the intended targets. Whether this approach translates into meaningful cognitive improvements and an acceptable safety profile will be determined through clinical testing. Alzheimer’s disease is a progressive neurodegenerative disorder and a leading cause of dementia. It can gradually affect memory, reasoning, communication and the ability to perform everyday activities. Existing treatments may help manage certain symptoms or slow disease progression in eligible patients, but substantial unmet needs remain, particularly in maintaining cognitive function. By evaluating NBI-567 as an adjunctive treatment, Neurocrine aims to determine whether targeting muscarinic receptors can provide additional cognitive benefits for adults who are already receiving established symptomatic therapy.
Phase 2 Trial to Enroll Approximately 135 Adults
The randomized, double-blind, placebo-controlled Phase 2 study is planned to enroll approximately 135 adults aged 50 to 85 years with mild to moderate Alzheimer’s disease. Eligible participants will be receiving stable treatment with an acetylcholinesterase inhibitor, a class of medicines commonly used to manage cognitive symptoms associated with the disease. Participants will be randomized to receive one of two dose levels of NBI-567 or a matching placebo. Treatment will be administered once daily during the 12-week treatment period. The study will evaluate the investigational drug’s efficacy, safety, tolerability and pharmacokinetics, which describe how the body absorbs, distributes and processes a medicine. The primary efficacy endpoint is the change from baseline in the Neuropsychological Test Battery composite score at Week 12. This assessment is intended to measure changes across several areas of cognitive performance. Secondary endpoints include changes in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 13 (ADAS-Cog13) and the Clinical Dementia Rating Sum of Boxes (CDR-SB) at Week 12. These measures help researchers assess cognitive symptoms and the severity of disease-related impairment. The controlled study design will allow investigators to compare outcomes between participants receiving NBI-567 and those receiving placebo, helping establish whether any observed changes may be attributable to the investigational treatment.
Advertisement
Clinical Results Will Guide Future Development
The initiation of this Phase 2 study marks an important milestone in Neurocrine Biosciences’ neurological drug development portfolio. The findings are expected to provide evidence on whether NBI-567 can improve cognitive performance while maintaining acceptable tolerability in the target population. Researchers will also examine pharmacokinetic data to better understand drug exposure and how different dose levels perform over the treatment period. These findings may help inform dose selection and subsequent clinical development. No efficacy results have been established from this newly initiated Phase 2 study. Further research will be needed to determine whether the treatment produces clinically meaningful benefits, how long any improvements may last and whether its safety profile supports continued development. For Neurocrine Biosciences, the study expands research into selective muscarinic receptor targeting across neurological and psychiatric disorders. Its outcome could help clarify the potential role of this mechanism in addressing cognitive symptoms associated with Alzheimer’s disease. The trial is an early clinical step rather than evidence of an approved new treatment. Future results will be important in determining whether NBI-567 can become a useful addition to existing care for people living with Alzheimer’s disease.
Source: Neurocrine Biosciences press release
