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.
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.
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.
Parallel
NBI-1117567
DrugNBI-1117567 will be administered per schedule specified in the arm description.
Placebo
DrugPlacebo matching to NBI-1117567 will be administered per schedule specified in the arm description.
Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85
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This trial is not recruiting at the moment. You can still explore other options:
