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Not yet recruitingNCT07832383Updated Sep 22, 2026

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

A Phase 2 interventional study of NBI-1117567 and Placebo in Alzheimer's Disease, sponsored by Neurocrine Biosciences. Not yet recruiting. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Neurocrine Biosciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

Keywords

  • Neurodegenerative disorder
  • Dementia
  • Cognition
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 135 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Browse Neurocrine Biosciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 .
  • 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
135 participants (estimated)

Study arms

  • Experimental
    NBI-1117567 Low Dose

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

    Drug: NBI-1117567

  • Experimental
    NBI-1117567 High Dose

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

    Drug: NBI-1117567

  • Placebo comparator
    Placebo

    Participants will receive placebo for 12 weeks.

    Drug: Placebo

Interventions

  • DrugNBI-1117567

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Day 85

Secondary outcomes

  1. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85

    Time frame: Baseline, Day 85

  2. Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85

    Time frame: Baseline, Day 85

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2028, 19 months later.

Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 19 months is below that.

Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartEst.
Oct 2026
Primary completionEst.
May 2028
CompletionEst.
Jun 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832383
Lead sponsor
Neurocrine Biosciences
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
May 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Neurocrine Medical Information Call Center
Contact
medinfo@neurocrine.com
1-877-641-3461
Clinical Development Lead
study director · Neurocrine Biosciences

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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