Research study to assess the potential of masupirdine in patients with agitation symptoms associated with memory loss

You likely can't join if

• 1.Female participants who are pregnant or breast feeding. 2.Sexually active females of childbearing potential and male participants are not practicing two different methods of birth control with their partner. 3.Has history of confirmed COVID-19 within 3 months prior to Visit 1. 4.Has a diagnosis of dementia due to other non-Alzheimer disorders. 5.Has a history of stroke, documented TIAs, and/or pulmonary embolism within the last 12 months. 6.Has a diagnosis of schizophrenia, bipolar disorder, or current untreated/uncontrolled MDD or participants whose C-SDD scores are suggestive of probable depression (ie, scores ≥12) at Visits 1 or 2. 7.Has symptoms of agitation that are not secondary to AD. 8.Has symptoms of delirium or history of delirium within 1 month prior to Visit 1. 9.Has used or will continue to use MAOIs, linezolid, tricyclic antidepressants, or intravenous methylene blue within 14 days prior to Visit 1. 10.Has uncontrolled cardiac disease or hypertension. 11.All antipsychotics are prohibited and should be discontinued as appropriate. 12.Centrally acting anticholinergic medications are prohibited. 13.CYP3A4 substrates with narrow therapeutic index are prohibited and should be discontinued as appropriate. 14.Use of any medications/supplements/foods with known inhibitoryinducer effects on CYP3A4 should be discontinued from screening through EOT visit. 15.Use of herbal and dietary supplements that cause liver injury. Participants on stable use for at least 4 months prior to Visit 1 are allowed; however, herbal and dietary supplement dose changes and new herbal and dietary supplements are not allowed during the study.
• 16.Has a history or current evidence of QT prolongation syndrome, or Torsade de Pointes, as determined by ECG at Visits 1 or 2. 17.Has bradycardia (100 bpm) on the ECG at Visits 1 or 2. 18.Has uncontrolled type-1 or type-2 diabetes (defined as HbA1c >6.5% at Visit 1). 19.Has cancer, a malignant tumor, or has been treated for an active malignancy within the past 5 years. Participants with stable untreated prostate or cervical cancer, localized squamous cell cancer, or basal cell cancer are permitted. 20.Has clinically significant hepatic impairment. 21.Is treated or likely to require treatment during the study with any medications prohibited by the study protocol. 22.Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator at Visits 1 or 2. 23.History of significant head injury, seizures, or any other unexplained, recurrent loss of consciousness for more than 15 minutes within 12 months of Visit 1. 24.Poorly controlled psychosis and other psychiatric disorder that, in the opinion of the investigator, would interfere with the participant’s ability to be compliant with the study protocol. 25.Known history of substance use disorder within 1 year prior to first dose of study drug, not including caffeine and nicotine. 26.Current implantable intracranial stimulator or history of intracranial ablation surgery. 27.Repetitive transcranial magnetic stimulation within 3 months prior to Visit 1. 28.Participation in experimental interventional treatments, including immunotherapy, for any aspects of AD in the past 6 months or 5 half-lives of the experimental drug product (whichever is longer), prior to the first dose of study drug. If the participant was on placebo arm of disease-modifying treatments, participation in this study is allowed. 29.Has been previously treated with masupirdine. 30.Use of recreational or medical marijuana within 4 weeks prior to the first dose of study drug or any time during the study. 31.Positive screen for illicit drugs of abuse, including phencyclidine, barbiturates, benzodiazepines, opiates, methadone, cocaine, cannabinoids, and amphetamines. 32.Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator’s judgment.