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

NCT ID
NCT07832383
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Neurocrine Biosciences
Conditions
Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: 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

Enrollment: 135 participants (Estimated).

What is being studied

  • Drug: NBI-1117567
  • Drug: Placebo

Who may be eligible

Ages
50 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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. Key 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.

Study locations

No study locations are listed in the registry data.

Study details

Start date
October 1, 2026
Primary completion date
May 1, 2028
Completion date
June 1, 2028
First posted
September 22, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07832383
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07832383 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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