Neurocrine Biosciences starts 135‑patient Alzheimer's cognition trial

A trial targeting 135 patients with Alzheimer's cognitive impairment has begun, as Neurocrine Biosciences, Inc. NASDAQNBIX announced on Tuesday. The Phase 2 study will compare NBI-'567 with placebo over 12 weeks as an addition to existing treatment.

The company's Oct. 20 announcement describes a randomized, double-blind study enrolling adults aged 50 to 85 with mild to moderate Alzheimer's disease. Participants will receive a low dose, a high dose or placebo while continuing stable treatment with an acetylcholinesterase inhibitor.

Neurocrine is an established San Diego biopharmaceutical company with a broad commercial portfolio of treatments for neurological and endocrine disorders and a pipeline of experimental medicines.

The NASDAQNBIX quote showed shares up 0.75 per cent at US$138.01 in Nasdaq trading at 9:31 a.m. EDT on Tuesday. The observation captures early trading after the announcement.

The primary endpoint is the change from baseline in a Neuropsychological Test Battery composite score at week 12. Secondary endpoints measure changes on the Alzheimer's Disease Assessment Scale-Cognitive Subscale and Clinical Dementia Rating Sum of Boxes over the same period.

The ClinicalTrials.gov record, NCT07832383, estimates primary completion in May 2028 and overall completion in June 2028. Its latest posted update, dated Sept. 22, still lists the study as not yet recruiting, preceding the company's initiation announcement.

The registry requires background medication to have been stable for at least three months before screening and to remain unchanged throughout treatment. Active-treatment arms include dose titration followed by 10 weeks at the target dose. Neurocrine did not specify a results announcement date.

NBI-'567 is designed to activate M1 and M4 muscarinic receptors, with a preference for M1, in pathways involved in learning and memory. The company says its selectivity is intended to minimize activity at other muscarinic receptor subtypes.

The study will assess safety, tolerability and pharmacokinetics, but the announcement provides no clinical safety results. It also does not disclose FDA feedback on whether this design could support an approval application.

"As a defining characteristic of Alzheimer's disease, cognitive impairment affects memory, attention, and other thinking abilities that significantly impact daily functioning," Neurocrine chief medical officer Eiry W. Roberts said in the release.

Muscarinic Rivals Target Different Symptoms

The trial enters a field addressing more than seven million Americans living with Alzheimer's disease, according to Neurocrine's Oct. 20 release. Other listed developers are pursuing muscarinic approaches, although their populations and treatment objectives differ.

Bristol Myers Squibb NYSEBMY described its Phase 3 ADEPT-2 study of Cobenfy for Alzheimer's-associated psychosis in a Dec. 3, 2025 update. Its primary endpoint measures hallucinations and delusions, separating that program's objective from Neurocrine's cognitive-performance test.

Anavex Life Sciences Corp. NASDAQAVXL described oral blarcamesine as targeting SIGMAR1 and muscarinic receptors in its March 23 update. That release discussed its Phase 2b/3 early Alzheimer's program and an open-label extension, a different development stage and population from Neurocrine's new study.

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Commercial Sales Support Pipeline Spending

Neurocrine reported cash, cash equivalents and marketable securities of US$482 million at June 30. Revenue for the quarter ended on that date totalled US$959 million, while research and development expense under generally accepted accounting principles was US$327 million.

The next dated company event is third-quarter results on Nov. 2, when holders can reassess the financial resources behind Neurocrine's expanding clinical pipeline.