Alzheimer's DiseasePhase 2NCT07832383
Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor
A Phase 2 study testing NBI-1117567 in people with Alzheimer's Disease, run by Neurocrine Biosciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- NBI-1117567
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- NBI-1117567, Placebo
- Keywords
- Neurodegenerative disorder, Dementia, Cognition
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117567Drug
NBI-1117567 will be administered per schedule specified in the arm description.
PlaceboDrug
Placebo matching to NBI-1117567 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| NBI-1117567 Low Dose | Experimental | Participants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks. Receives: 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. Receives: Drug: NBI-1117567 |
| Placebo | Placebo comparator | Participants will receive placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
Measured: 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
Measured: Baseline, Day 85
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85
Measured: Baseline, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832383
- Sponsor's protocol ID
- NBI-1117567-ADC2038
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No