Dementia Clinical Trials

• Is a male or female aged 55 to 90 years, inclusive, at Screening.

• Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.

• Meets clinical criteria for Possible AD or Probable AD.

• Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.

• Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.

• Have an identified study partner who should have daily contact (approximately 10 hours a week or more).

• History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.

• CGI-S scale with a score ≥ 4 at Screening and Baseline.

• AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:

∙ Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR

‣ Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items

⁃ MMSE score of 8 to 22, inclusive, at Screening.