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

NCT07832383 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: NBI-1117567-ADC2038
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to evaluate the efficacy on improving cognitive performance as well as the safety, tolerability, and pharmacokinetics (PK) of NBI-1117567 administered once daily (QD) in adults with mild to moderate AD who are receiving stable treatment with an acetylcholinesterase inhibitor.

Conditions

Alzheimer's Disease

Keywords

Neurodegenerative disorder; Dementia; Cognition

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Day 85

Secondary Outcomes (2)

• 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

Study Arms (3)

NBI-1117567 Low Dose

EXPERIMENTAL

Participants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks.

Drug: NBI-1117567

NBI-1117567 High Dose

EXPERIMENTAL

Participants will receive the titration dose of NBI-1117567 followed by the target dose (high dose) for 10 weeks.

Drug: NBI-1117567

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for 12 weeks.

Drug: Placebo

Interventions

NBI-1117567 DRUG

NBI-1117567 will be administered per schedule specified in the arm description.

NBI-1117567 High Dose; NBI-1117567 Low Dose

Placebo DRUG

Placebo matching to NBI-1117567 will be administered per schedule specified in the arm description.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

1-877-641-3461; medinfo@neurocrine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share