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NBI-1117567 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| NBI-1117567 Low Dose | EXPERIMENTAL | Participants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks. |
| NBI-1117567 High Dose | EXPERIMENTAL | Participants will receive the titration dose of NBI-1117567 followed by the target dose (high dose) for 10 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| NBI-1117567 | DRUG | NBI-1117567 will be administered per schedule specified in the arm description. |
| Placebo | DRUG | Placebo matching to NBI-1117567 will be administered per schedule specified in the arm description. |
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 Screeni...
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NBI-1117567 is an investigational small molecule being developed by Neurocrine Biosciences, Inc. for Alzheimer's disease. It is currently in Phase 2 clinical development and has not been approved by the FDA. The program is focused on patients with mild to moderate Alzheimer's disease who are already taking a background acetylcholinesterase inhibitor.
NBI-1117567 is being studied for the treatment of mild to moderate Alzheimer's disease in participants who are taking a background acetylcholinesterase inhibitor. It is an investigational therapy and is not approved for any use. Its only registered clinical study enrolls adults aged 50 years and older with a diagnosis of Alzheimer's disease.
NBI-1117567 is developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company is the sponsor of the drug's clinical program in Alzheimer's disease.
NBI-1117567 is in Phase 2 clinical development. It is an investigational small molecule and is not FDA approved. The Phase 2 study is registered as not yet recruiting, and no completed trials of NBI-1117567 have been recorded.
NBI-1117567 is being evaluated in one Phase 2 trial, NCT07832383, titled Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor. The study is not yet recruiting and is planned to enroll 135 participants aged 50 years and older.
The Phase 2 trial NCT07832383 is a randomized, double-blind, placebo-controlled study of NBI-1117567 in participants with mild to moderate Alzheimer's disease who are taking a background acetylcholinesterase inhibitor. It is planned to enroll 135 participants of all sexes, aged 50 years and older, and does not enroll healthy volunteers.