Phase 1b evaluation of NBI-1117569 in adults with a diagnosis of Alzheimer’s Disease (AD)
Research type
Research Study
Full title
A Phase 1b, Multicenter, Randomized, Rising-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of NBI-1117569 in Adults With a Primary Diagnosis of Mild to Moderate Alzheimer’s Disease
IRAS ID
1013343
Contact name
Lauren Pittard
Contact email
Sponsor organisation
Neurocrine Biosciences, Inc.
ISRCTN Number
ISRCTN10994097
Research summary
Neurocrine Biosciences, Inc. is sponsoring this research to learn more about a possible treatment for symptoms of Alzheimer’s disease (AD). AD is a medical condition that affects memory, thinking, and behaviour. There are available treatments that help with AD symptoms, but they do not work for everyone and are often associated with side effects. Therefore, other treatment options for people with AD are needed. NBI-1117569 is an experimental drug being studied for symptoms of AD.\n\nThe main goal of the trial is to learn about the safety and tolerability of NBI-1117569 in participants with AD. Researchers will study any new or worsening medical problems that participants have during and after treatment, including possible side effects.\nThis trial will include participants 50 to 85 years old with mild to moderate AD. Participants with certain medical conditions or who need to take certain medications may not be able to take part. \n\nParticipants will take increasing doses of NBI-1117569 or placebo (an identical-looking treatment with no active ingredients) by mouth once daily for up to 14 days. Participants will also continue to take their standard AD medications at stable doses. \n\nThis trial will be conducted at approximately 8 specialist clinical research centres in the United Kingdom.\n\nParticipants will be in the trial for up to approximately 2 months, which includes screening, treatment, and follow-up after receiving their last dose.\n\nParticipants will visit a trial site up to 17 times. Some participants will also need to be confined at the trial site for at least 3 nights. During site visits, trial doctors will collect blood and urine samples, perform physical examinations, and check participants’ heart health, among others.\n\nParticipants may or may not receive any benefits from this trial. However, this trial will help researchers understand more about possible treatments for symptoms of AD.
REC name
Wales REC 1
REC reference
26/WA/0028
Date of REC Opinion
8 Apr 2026
REC opinion
Further Information Favourable Opinion