Dementia Clinical Trials

∙ \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:

∙ i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.

∙ ii) If no historical evidence available:

∙ A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.

∙ B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:

• Amyloid PET.

• Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.

‣ Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).

⁃ Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:

‣ i) Attend all visits and report on participant's status.

∙ ii) Oversee participant compliance with medication and study procedures.

∙ iii) Participate in the study assessments and provide informed consent to participate in the study.

• History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).

• AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).

• CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).

• At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):

• i) 1 or more aggressive behaviors occurring at least several times per week.

∙ ii) 2 or more aggressive behaviors occurring at least once or twice per week.

∙ iii) 3 or more aggressive behaviors occurring less than once per week.