Can a daily pill sharpen thinking in Alzheimer's?
NCT ID NCT07832383
First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time
Summary
Researchers are testing an experimental drug called NBI-1117567 in adults with mild to moderate Alzheimer's disease who already take a standard memory medication. The trial compares NBI-1117567 taken once daily with a placebo to see whether it improves performance on thinking and memory tests after about three months. Participants continue their usual acetylcholinesterase inhibitor at the same dose throughout the study, and researchers also track safety and how the body processes the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called NBI-1117567
- What this could lead to
- If it works, NBI-1117567 could become a new add-on option to help people with mild to moderate Alzheimer's hold onto thinking and memory skills for longer.
- What could go wrong
- This is a mid-stage trial with about 135 people, so any cognitive benefit seen over roughly three months may be small or fade. The drug may cause side effects that outweigh its benefits, and results in this group may not apply to everyone with Alzheimer's.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 135 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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